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

Recall Z-1852-2019 — Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

U.S. FDA — Device Enforcement · United States · 2019-05-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1852-2019
Date of alert
2019-05-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Maquet Cardiovascular Us Sales, Llc
Product category
device
Product type
Devices
Reported risk: 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
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.

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