POWERLED II

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED II. IT WAS STATED THAT PAINT WAS CHIPPING OFF ON THE LIGHT. NO PATIENT INVOLVEMENT AND NO INJURY HAVE BEEN REPORTED.

Additional Manufacturer Narrative

EVENT SITE NAME: (B)(6). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.