Recall Z-1308-2022 ยท FSY Light, Surgical, Ceiling Mounted
Getinge Usa Sales Inc
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDVST229037A VST66DF
| Date | Jun 30, 2022 (initiated May 6, 2022) |
| Status | Open, Classified |
| Reason | Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field. |
| Root cause | Process change control |
| Action | On May 6, 2022, the firm notified affected customers through an Urgent Medical Device Correction letter. Customers were instructed to continue to perform daily inspections per the IFU, which include checking for any chipped or missing paint. If you observe paint chipping or detachment, the firm recommends that you stop using the device and contact your Getinge service representative to schedule an appointment to replace the part free of charge. The firm is requesting that customers contact their Getinge service representative to have the part replaced if chipped or missing paint is observed th |
| Quantity | 337 (US); 8594 (OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, CT, GA, IA, ID, KS, KY, LA, MA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130513 | VOLISTA 400; VOLISTA 600 Maquet S.A.S., May 8, 2013 |