![]() The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide including USA, Europe, Far East, Canada, Japan, Australia, Middle East, Mexicoġ A record in this database is created when a firm initiates a correction or removal action. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers. Distributors were asked to forward individual serial number packages to their customers. International packages were sent to each distributor via Fed-x/DHL tracking on. Candela services will contact the customers and schedule upgrades. ![]() Internal component may overheat causing the possibility of risk of fire or smokeĬandela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on. Class 2 Device Recall Candela Corporation Vbeam Aesthetica Laser SystemĬandela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 20 Vbeam Aesthetica w/ gray enclosure and rose colored displayĩ914-0320-XXXXX, where XXXX = 0001 thru 0513 (a sequential # independent of it being a Perfecta, Platinum, or Aesthetica model) ![]()
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