FDA Cosmetic Device Recalls

MAUDE - Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Also, warning letters issued to device makers for FDA violations.

FDA Cosmetic Device Recalls

PostPosted by DCNGA » Fri Jan 20, 2012 10:21 pm

Class 2 Recall

Lumenis

Date Posted February 16, 2006 Recall Number Z-0529-06 Product Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692 Code Information Software versions lower than 2.02

All serial numbers; All codes Recalling Firm/Manufacturer Lumenis Inc.2400 Condensa StSanta Clara, California 95051-0901 Reason forRecall

Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.

Action On 4/8/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
. Quantity in Commerce 142 units Distribution The product was released for distribution to 124 consignees nationwide. One international consignee includes: New Zealand. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

**************************************************************************************************************************************************

http://www.totalrecallinfo.com/freerecalls.php?id=15350

RECALL INFORMATION

Jan 14---Lumenis Ltd. recalls Lumenis One DISPLAYS---Canada

Manufacturer: -See Below-


Product: Medicals

Start Date: 2010-01-14 End Date: 2010-02-14


Manufacturer
Lumenis Ltd.

Trade Name
Lumenis One

Recall Start Date
09-12-03

Recall Number
52100

Hazard Classification
Type II

Model or Catalog #
GAL 150000

Lot or Serial #
>10 Numbers, Contact Manufacturer

Reason for Recall
To address a found computer glitch, which when adjusting the default settings in intense pulse light triple pulse mode, it has been found that the GUI display does not accurately display the true adjusted power.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA Cosmetic Device Recalls

PostPosted by DCNGA » Fri Jan 20, 2012 10:39 pm

Solta Recall:

Class 2 RecallFraxel re:store® Dual Laser System

Date Posted February 01, 2011 Recall Number Z-1010-2011 Product Fraxel re:store® Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology.

Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA

The Fraxel re:store® Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue. Code Information Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426 Recalling Firm/Manufacturer Solta Medical, Inc.25881 Industrial BlvdHayward, California 94545-2991 For Additional Information Contact Kristine Foss 510-259-7119

Reason forRecall The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.

Action The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further.

If you have any questions, please call Solta Product Support at (510) 259-7291. Quantity in Commerce 352 units Distribution Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA Cosmetic Device Recalls

PostPosted by DCNGA » Fri Jan 20, 2012 10:44 pm

Candela V-Beam Recall 2006

Class 2 Recall

Date Posted May 04, 2006 Recall Number Z-0842-06 Product Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry.

Model Number: 9914-00-0300 Code Information Serial Number: SN 9998;

9914-0300-0001 through 9914-0300-0058 Recalling Firm/Manufacturer Candela Laser Corporation530 Boston Post RdWayland, Massachusetts 01778-1833 For Additional Information Contact Edward Gramer508-358-7637

Reason forRecall Handle fires even when the finger is off the switch

Action Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system. Quantity in Commerce 59 units Distribution Nationwide
Foreign: Canada, Spain, Japan, Germany, France, Switzerland
"It is a good thing to learn caution from the misfortunes of others."

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Re: FDA Cosmetic Device Recalls

PostPosted by DCNGA » Fri Jan 20, 2012 10:45 pm

Candela VBeam 2007:

Class 2 RecallCandela Corporation Vbeam Aesthetica Laser System

Date Posted February 15, 2007 Recall Number Z-0510-2007 Product Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display Code Information 9914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model) Recalling Firm/Manufacturer Candela Laser Corporation530 Boston Post RdWayland, Massachusetts 01778-1833 For Additional Information Contact Ed Gramer508-358-7637

Reason forRecall Internal component may overheat causing the possibility of risk of fire or smoke

Action Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Quantity in Commerce 474 laser systems total (all models) Distribution Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico


AND


Class 2 RecallCandela Corporation Vbeam Aesthetica Laser System

Date Posted February 15, 2007 Recall Number Z-0508-2007 Product Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display Code Information 9914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model) Recalling Firm/Manufacturer Candela Laser Corporation530 Boston Post RdWayland, Massachusetts 01778-1833 For Additional Information Contact Ed Gramer508-358-7637

Reason forRecall Internal component may overheat causing the possibility of risk of fire or smoke

Action Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Quantity in Commerce 474 laser systems total (all models) Distribution Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico

AND

2 RecallCandela Corporation Vbeam Aesthetica Laser System

Date Posted February 15, 2007 Recall Number Z-0513-2007 Product Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display Code Information 9914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model) Recalling Firm/Manufacturer Candela Laser Corporation530 Boston Post RdWayland, Massachusetts 01778-1833 For Additional Information Contact Ed Gramer508-358-7637

Reason forRecall Internal component may overheat causing the possibility of risk of fire or smoke

Action Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Quantity in Commerce 474 laser systems total (all models) Distribution Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico

AND

Class 2 RecallCandela Corporation Vbeam Aesthetica Laser System

Date Posted February 15, 2007 Recall Number Z-0512-2007 Product Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display Code Information 9914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model) Recalling Firm/Manufacturer Candela Laser Corporation530 Boston Post RdWayland, Massachusetts 01778-1833 For Additional Information Contact Ed Gramer508-358-7637

Reason forRecall Internal component may overheat causing the possibility of risk of fire or smoke

Action Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Quantity in Commerce 474 laser systems total (all models) Distribution Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico

AND

Class 2 RecallCandela Corporation Vbeam Aesthetica Laser System

Date Posted February 15, 2007 Recall Number Z-0509-2007 Product Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display Code Information 9914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model) Recalling Firm/Manufacturer Candela Laser Corporation530 Boston Post RdWayland, Massachusetts 01778-1833 For Additional Information Contact Ed Gramer508-358-7637

Reason forRecall Internal component may overheat causing the possibility of risk of fire or smoke

Action Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Quantity in Commerce 474 laser systems total (all models) Distribution Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexico
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA Cosmetic Device Recalls

PostPosted by DCNGA » Fri Jan 20, 2012 11:02 pm

Titan XL:

Class 2 Recall Titan XL

Date Posted November 09, 2010 Recall Number Z-0329-2011 Product Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA

Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness. Code Information All products manufactured before October 1, 2009 with gold plated end blocks. Recalling Firm/Manufacturer Cutera Inc3240 Bayshore BlvdBrisbane, California 94005 Reason forRecall Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.

Action Cutera sent Certified letters sent to all consignees on May 8, 2010. The letter identified the product, the problem, and the action the consignees should take. Consigness were instructed to immediately stop using the handpiece and complete the attached Recall Tracker Form. A second letter was sent to customers who received a replacement handpiecce but did not return the affected devices. All affected products were to be exchanged for new or reworked devices.

For questions contact customer service at (888) 428-8372, ext 5561. Quantity in Commerce 1,344 units Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OK, OR, PA, OH, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cypress, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan,
Lle de la Reunion, Mexico, New Zealand, Phillipines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, UAE, and Ukraine.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: FDA Cosmetic Device Recalls

PostPosted by hopeful19 » Sat Jan 21, 2012 6:52 pm

Class 2 Recall
Lumenis


Date Posted February 23, 2006
Recall Number Z-0556-06
Product Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551
Code Information All codes, All serial numbers
Recalling Firm/
Manufacturer Lumenis Inc.
2400 Condensa St
Santa Clara, California 95051-0901
For Additional Information Contact Ms. Connie Hoy
408-764-3303
Reason for
Recall During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.
Action On 2/9/06, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. In May 2005, Lumenis mailed a ''Dear Doctor'' letter to LightSheer Diode Laser System customers describing more detailed cleaning procedures to be used on the sapphire tips due to skin burns patients'' were experiencing from debris build-up on the tip. .
Quantity in Commerce 3,426 units
Distribution The product was released for distribution to 3,426 consignees nationwide. There are 48 international consignees.
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
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Re: FDA Cosmetic Device Recalls

PostPosted by hopeful19 » Sat Jan 21, 2012 6:53 pm

Class 2 Recall
Lumenis


Date Posted March 02, 2006
Recall Number Z-0545-06
Product Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104
Code Information All codes manufactured prior to November 4, 2003.
Recalling Firm/
Manufacturer Lumenis Inc.
2400 Condensa St
Santa Clara, California 95051-0901
For Additional Information Contact Ms. Connie Hoy
408-764-3303
Reason for
Recall The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.
Action On 7/26/04 and 2/1/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned for correction.
Quantity in Commerce Approx. 1436 units
Distribution Nationwide. The product was released for distribution to 1431 consignees worldwide. International consignees include: Australia, Canada, India, Netherlands, Argentina, France, Malaysia, Italy, Brazil, Mexico, China, Colombia, Thailand, Holland, Japan, and Venezuela. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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Re: FDA Cosmetic Device Recalls

PostPosted by hopeful19 » Sun Jan 22, 2012 8:00 pm

This is not a cosmetic laser but what is interesting is why it was recalled.


Class 2 Recall
Endo Ocular Directional Laser Probe


Date Posted September 30, 2010
Recall Number Z-2652-2010
Product Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO
Code Information Model numbers: GA-0040061;, GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA-0040066 Lot numbers: 942439; 946478; 947498; 942440; 947496; 010120; and 947501
Recalling Firm/
Manufacturer Lumenis, Inc.
3959 W 1820 S
Salt Lake City, Utah 84104
Consumer Instructions No consumer action necessary
For Additional Information Contact Customer Service
877-586-3647
Reason for
Recall Firm did not have proper 510(K) clearance.
Action Lumenis sent letters to all customers on 7/27/10 instructing them to review their inventory, isolate affected product, complete a recall verification form and return all affected product to them.
Quantity in Commerce 250 probes (25 boxes, each containing 10 probes)
Distribution FL, IL, MD, CO and TX
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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Re: FDA Cosmetic Device Recalls

PostPosted by hopeful19 » Sun Jan 22, 2012 8:04 pm

Latest Medical Device Recalls by Lumenis
Recall number: Z-0585-2008
Class 2
Date posted: 2008-04-09
Reason for the recall: Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.

Recall number: Z-0028-2007
Class 2
Date posted: 2006-10-12
Reason for the recall: Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.

Recall number: Z-0545-06
Class 2
Date posted: 2006-03-02
Reason for the recall: The BP/Notch filter may be out of specification and may cause injury to the patient's eye due to high power (energy) delivered by the Laser System during medical procedures.

Recall number: Z-0556-06
Class 2
Date posted: 2006-02-23
Reason for the recall: During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip.

Recall number: Z-0529-06
Class 2
Date posted: 2006-02-16
Reason for the recall: Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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Re: FDA Cosmetic Device Recalls

PostPosted by hopeful19 » Sun Jan 22, 2012 8:44 pm

Found them all together in one place so decided to post. Delete if you think not needed.


Latest Medical Device Recalls by Candela
Recall number: Z-0509-2007
Class 2
Date posted: 2007-02-15
Reason for the recall: Internal component may overheat causing the possibility of risk of fire or smoke

Recall number: Z-0510-2007
Class 2
Date posted: 2007-02-15
Reason for the recall: Internal component may overheat causing the possibility of risk of fire or smoke

Recall number: Z-0511-2007
Class 2
Date posted: 2007-02-15
Reason for the recall: Internal component may overheat causing the possibility of risk of fire or smoke

Recall number: Z-0512-2007
Class 2
Date posted: 2007-02-15
Reason for the recall: Internal component may overheat causing the possibility of risk of fire or smoke

Recall number: Z-0513-2007
Class 2
Date posted: 2007-02-15
Reason for the recall: Internal component may overheat causing the possibility of risk of fire or smoke

**************************************************************
Recall by Candela - Z-0842-06
Recall Number: Z-0842-06
Recall Class: 2
Recall Report Date: 2006-05-04
Recall Reason: Handle fires even when the finger is off the switch
Consumer Instructions: Date Posted
Recommended Action: Candela notified Service Representaives by email on 1/17/06 providing Technical Service Bulletin, listing of laser systems to be reworked and script to address customer questions during visit to correct system.
Quantity in Commerce: 59 units
Distribution Areas: Nationwide \ Foreign: Canada, Spain, Japan, Germany, France, Switzerland
"There's almost no risk involved," says Stephen Fanning, CEO of Solta Medical, which owns Fraxel.

The world is a dangerous place to live, not because of the people who do evil, but rather those who sit back & let it happen.
-Einstein
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