Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1308-2022 — 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 VST6

U.S. FDA — Device Enforcement · United States · 2022-05-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1308-2022
Date of alert
2022-05-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Getinge Usa Sales Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3700712400873
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.