Medical Device Recalls United Kingdom (MHRA)

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.

Medical Device Recalls United Kingdom (MHRA)

PostPosted by hopeful19 » Sat Jan 21, 2012 11:11 pm

Therapy, lasers - Candela Corporation - Vbeam Perfecta, Vbean Platinum and Vbeam Aesthetica
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Device type:
Manufacturer: Candela Corporation
Device name: Vbeam Perfecta, Vbean Platinum
Manufacturer's reference number: unk
MHRA reference number: 2007/001/029/081/010
Summary:

Note: We place field safety notices on our website for information. They will not normally require further action unless you have been contacted directly by the manufacturer or we have issued supplementary advice.

Download documents:

Candela Corporation - 21 February 2007 (224Kb)

I couldn't copy it as it was a pdf so go to the link. Basically summed up says;

"Your system has been identified as having the potential for an internal component to overheat, which could posr the risk of smoke or fire."

http://www.mhra.gov.uk/Safetyinformatio ... CON2030342
"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
hopeful19
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Re: Medical Device Recalls United Kingdom (MHRA)

PostPosted by hopeful19 » Sat Jan 21, 2012 11:22 pm

http://www.mhra.gov.uk/home/groups/fsn/ ... 111455.pdf


DEVICE CORRECTION


January 14, 2011


To: All Solta Medical International Fraxel re:store® DUAL System Distributors

Re: Fraxel re:store® DUAL Software Update – Versions 4.9.2 – 5.0.0


We are effecting a mandatory update of the software for our entire installed base of Fraxel
re:store® DUAL Laser Systems. All systems with software versions 4.9.2 are to be updated to
the new software version 5.0.0 by means of a field update.

Following are the affected catalog #s:

MC-SYS-SR1500-D-I-LOANER, MC-SYS-SR1500-D-INTL,
MC-SYS-SR1500-D-UPG-INTL, MC-SYS-SR1500-D-UPG-US,
MC-SYS-SR1500-D-US, and MC-SYS-SR1500-D-US-LOANER.

The reason for this update is because of a single reported incidence of inadvertent firing of the
laser in one Fraxel re:store® DUAL Laser System. In order for us to ensure that this error
cannot recur, the new software version must be installed on each system. To meet our
regulatory responsibilities, we are required to conduct this update process in a timely manner.
Our target deadline for completion is February 28, 2011.

In order to accomplish this update, we need your assistance. The software installation process
requires that the enclosed USB stick be inserted into the back of the Fraxel re:store® DUAL
Laser System, and that the steps set forth in the accompanying instructions be followed to
complete the process. Please update your demo system first and then, work your way through
the enclosed list of your customers, as you schedule your travel during the rest of the month.
Each update will take less than 10 minutes, which includes the system Self Test and
completion of documentation as proof that the update was performed correctly. Please follow
the instructions carefully and remember to retain the USB stick each time you update a system
so you will have it for the next one. When you have updated all systems on the list, you can
return the USB stick in the envelope provided.

Also, you will note that any system with software version 4.9.1 is not to be updated by you
because these systems require re-calibration after the software is updated. You can advise
any of your customers with these systems to expect a call from one of your Service personnel.


Please ensure that the documentation is completed and returned promptly to:
Product Support
Solta Medical
25881 Industrial Blvd.
Hayward, CA 94545

Any new or upgraded Fraxel re:store® DUAL systems shipping from Hayward after December
1, 2010, have the new software version incorporated, so there is no need for you to follow up
with customers who have received these systems.

If you have any questions, please call Solta Product Support at +1 877-782-2286 and select
Option 2.

Sincerely,



Clint Carnell
Chief Operating Officer
Solta Medical






Enclosures



DEVICE CORRECTION


January 11, 2011



To: All Solta Medical International Fraxel re:store® DUAL System Representatives


Re: Fraxel re:store® DUAL Software Update – Versions 4.9.2 – 5.0.0


We are effecting a mandatory update of the software for our entire installed base of Fraxel
re:store® DUAL Laser Systems. All systems with software versions 4.9.2 are to be updated to
the new software version 5.0.0 by means of a field update.

Following are the affected catalog #s:

MC-SYS-SR1500-D-I-LOANER, MC-SYS-SR1500-D-INTL,
MC-SYS-SR1500-D-UPG-INTL, MC-SYS-SR1500-D-UPG-US,
MC-SYS-SR1500-D-US, and MC-SYS-SR1500-D-US-LOANER.

The reason for this update is because of a single reported incidence of inadvertent firing of the
laser in one Fraxel re:store® DUAL Laser System. In order for us to ensure that this error
cannot recur, the new software version must be installed on each system. We want to conduct
this update process in a timely manner, with a target deadline for completion of February 28,
2011.

In order to accomplish this update, we need your assistance. The software installation process
requires that the enclosed USB stick be inserted into the back of the Fraxel re:store® DUAL
Laser System, and that the steps set forth in the accompanying instructions be followed to
complete the process. Please update your demo system first and then, work your way through
the enclosed list of your customers, as you schedule your travel during the rest of the month.
Each update will take less than 10 minutes, which includes the system Self Test and
completion of documentation as proof that the update was performed correctly. Please follow
the instructions carefully and remember to retain the USB stick each time you update a system
so you will have it for the next one. When you have updated all systems on the list, you can
return the USB stick in the envelope provided.

Also, you will note that any system with software version 4.9.1 is not to be updated by you
because these systems require re-calibration after the software is updated. You can advise
any of your customers with these systems to expect a call from one of our Service personnel.






Please ensure that the documentation is completed and returned promptly to:
Product Support
Solta Medical
25881 Industrial Blvd.
Hayward, CA 94545

Any new or upgraded Fraxel re:store® DUAL systems shipping from Hayward after December
1, 2010, have the new software version incorporated, so there is no need for you to follow up
with customers who have received these systems.

If you have any questions, please call Solta Product Support at +1 877-782-2286 and select
Option 2.


Sincerely,

Madeleine Lyell
Senior Product Manager, Fraxel
Solta Medical
"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
hopeful19
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Long Time Member
 
Posts: 1580
Joined: Fri Jun 18, 2010 5:47 pm


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