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 » Tue Sep 20, 2011 11:44 am

http://www.accessdata.fda.gov/scripts/c ... m?ID=50059

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
"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 » Tue Sep 20, 2011 11:46 am

http://www.accessdata.fda.gov/scripts/c ... m?id=48150

Class 2 Recall Lumenis

Date Posted October 12, 2006 Recall Number Z-0028-2007 Product Lumenis brand DuoTome SideLite® 550 Micron Delivery System; laser systems for ablating soft tissue.

Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA Code Information Lot/Batch Numbers:


37600206, 38030206, 38470206, 39110306, 39660406, 40480506, 41040506, 42110606, 42550706,
37640206, 38120206, 38480206, 39200306, 39670406, 40490506, 41050506, 42120606, 42560706,
37650206, 38150206, 38510206, 39210306, 39680406, 40520506, 41080506, 42200606, 42570706,
37660206, 38160206, 38520206, 39220306, 39690406, 40530506, 41090506, 42210606, 42580706,
37700206, 38170206, 38530206, 39240306, 39770406, 40570506, 41100506, 42280606, 42650706,
37710206, 38200206, 38700306, 39250306, 39800406, 40580506, 41210506, 42290606, 42680706,
37720206, 38210206, 38710306, 39260306, 39810406, 40590506, 41310506, 42300606, 42740706,
37730206, 38230206, 38720306, 39270306, 39820406, 40600506, 41360506, 42310606, 42810706,
37740206, 38240206, 38730306, 39280306, 39830406, 40610506, 41390506, 42320606, 42890706,
37750206, 38300206, 38740306, 39460306, 39840406, 40690506, 41450506, 42330606, 43000706,
37760206, 38310206, 38800306, 39470306, 39880406, 40710506, 41470506, 42350606, 43010706,
37770206, 38380206, 38810306, 39530306, 39890406, 40720506, 41500506, 42360606, 43060706,
37800206, 38390206, 38830306 39540306, 39900406, 40730506, 41610606, 42380606, 43150706,
37810206, 38400206, 38840306, 39550306, 40180406, 40930506, 41750606, 42410606, 43190706,
37820206, 38410206, 38920306, 39560306, 40200406, 40940506, 41880606, 42420606, 43200706,
37890206, 38420206, 38930306, 39570306, 40340406, 40960506, 41890606, 42430606, 43210706,
37910206, 38430206, 38970306 39580306, 40390406, 40970506, 41900606, 42460706, 43220706,
37960206, 38440206, 38980306, 39590306, 40430406, 40980506, 41930606, 42490706, 43270706,
37970206, 38450206, 38990306, 39600306, 40460506, 41020506, 41990606, 42500706, 43280706,
37980206, 38460206, 39000306, 39650306, 40470506, 41030506, 42000606, 42540706, 43410706 Recalling Firm/Manufacturer Lumenis Inc.2400 Condensa StSanta Clara, California 95051-0901 For Additional Information Contact Ms. Lisa Scott408-764-3303

Reason forRecall 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.
Action On 8/26/06, the firm initiated the recall and its notification was via letters and phone calls requesting return of affected product. Quantity in Commerce 10,815 Distribution Worldwide, including USA, Japan, Europe, Hong Kong, Russia and Canada.
"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 » Tue Sep 20, 2011 11:51 am

http://www.accessdata.fda.gov/scripts/c ... m?id=45535

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."

"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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DCNGA
 
Posts: 5367
Joined: Fri Jun 18, 2010 3:16 pm
Location: US


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