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

Recall Z-1482-2018 — Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. F

U.S. FDA — Device Enforcement · United States · 2018-03-01 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1482-2018
Date of alert: 2018-03-01
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Draeger Medical, Inc.
Product category: device
Product type: Devices

Reported risk: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

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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