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

Recall Z-0768-2024 — Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 400

U.S. FDA — Device Enforcement · United States · 2023-11-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0768-2024
Date of alert: 2023-11-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Getinge Usa Sales Inc
Product category: device
Product type: Devices

Reported risk: A potential for a light system to fall in the operating room.

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.

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