VOLISTA STANDOP

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP. IT WAS STATED THAT PIECES OF PAINT WERE MISSING ON THE LIGHT. NO PATIENT INVOLVEMENT AND NO INJURY HAVE BEEN REPORTED.

Additional Manufacturer Narrative

(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.