FDA Device recall Z-1853-2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
- FDA Device
- Class II
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class II recall of Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP by Maquet Cardiovascular Us Sales, citing potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1853-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2019-07-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
Product
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
Reason
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
Identifiers
| code_info | Serial Numbers: 28004 31006 31065 31066 31067 31068 31071 35010 35012 35044 35045 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1853-2019%22
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