FDA Device recall Z-1308-2022
VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF…
- FDA Device
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF… by Getinge Usa Sales, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1308-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-06 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Getinge Usa Sales |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Product Code UDI Product Description ARD568811901 N/A VLT600SF AIM STP ARD568811911 N/A VLT600SF AIM STP ARD568811951…Product Code UDI Product Description ARD568811901 N/A VLT600SF AIM STP ARD568811911 N/A VLT600SF AIM STP ARD568811951 N/A VLT600DF AIM STP ARD568811961 N/A VLT600DF AIM STP ARD568812951 N/A VLT400DF AIM STP ARD568821911 N/A VLT600SF AIM STP QL ARD568821961 N/A VLT600DF AIM STP QL ARD568831961 N/A VLT600DF AIM STP ARDROL309018A 3700712400873 VST60 AIM ROL ARDROL309022A 3700712400866 VST40 TK AIM ROL B ARDROL309023A 3700712400903 VST60 TK AIM ROL B ARDVST229000A 3700712401603 VST60SF AIM ARDVST229001A 3700712401566 VST60DF AIM ARDVST229002A 3700712401764 VST66SF AIM ARDVST229003A 3700712401726 VST66DF AIM ARDVST229034A 3700712401597 VST60SF ARDVST229035A 3700712401559 VST60DF ARDVST229036A 3700712401757 VST66SF ARDVST229037A 3700712401719 VST66DF Serial Numbers: AR500002 AR500005 500000 500005 568811961AR031047 568811961AR031052 00002 00005 00006 00007 500005 510001 510002 510003 510004 510005 500029 500030 38009 38026 00125 00126 AR038016 AR038013 00113 500046 500069 AR038019 AR03801 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1308-2022%22
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