Medical Device Recall Listings Canada

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 Recall Listings Canada

PostPosted by hopeful19 » Sat Jan 21, 2012 8:44 pm

Manufacturer
Lumenis Ltd.
Recall Posting Date
2007-04-16
Trade Name
Surgical Duotome Sidelite Fibre for Holmiums
Recall Start Date
2006-08-29
Recall Number
32295
Hazard Classification
Type III
Model or Catalog #
0623-703-01
Lot or Serial #
3912, 4011, 4116
Reason for Recall
1) Absence of black indicator markings on the metal tip and 2) fiber degradation (degradation of fiber, detachment of metal cap, and fiber lasing straight) during use for devices manufactured after Feb.1
"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 Recall Listings Canada

PostPosted by hopeful19 » Sat Jan 21, 2012 8:45 pm

Manufacturer
Lumenis Ltd.
Recall Posting Date
2010-01-04
Trade Name
Lumenis One
Recall Start Date
2009-12-03
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.
"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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Posts: 1580
Joined: Fri Jun 18, 2010 5:47 pm

Re: Medical Device Recall Listings Canada

PostPosted by hopeful19 » Sat Jan 21, 2012 8:50 pm

Manufacturer
Candela Corporation
Recall Posting Date
2007-03-05
Trade Name
A) Candela Vbeam Perfecta
B) Candela Vbeam Platinum
C) Candela Vbeam Aesthetica
Recall Start Date
2007-01-17
Recall Number
34048
Hazard Classification
Type II
Model or Catalog #
A) 9914-XX-0300
B) 9914-XX-0310
C) 9914-XX-0320
Lot or Serial #
A) 9914-0300-0001 to/à - 0513
B) 9914-0310-0001 to/à - 0513
C) 9914-0320-0001 to/à - 0513
Reason for Recall
System has the potential for an internal component to overheat, which could pose the risk of smoke and fire.
"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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Posts: 1580
Joined: Fri Jun 18, 2010 5:47 pm

Re: Medical Device Recall Listings Canada

PostPosted by hopeful19 » Sun Jan 22, 2012 12:08 am

http://www.hc-sc.gc.ca/ahc-asc/media/ad ... as-eng.php

To further research Canadian Data base use the link above.
"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
Long Time Member
Long Time Member
 
Posts: 1580
Joined: Fri Jun 18, 2010 5:47 pm


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