Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Candela Corporation Vbeam Aesthetica Laser System		see related information
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 Corporation
530 Boston Post Rd
Wayland, Massachusetts 01778-1833
For Additional Information Contact Ed Gramer
508-358-7637
Reason for
Recall		 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
 
-
-