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

Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe. — recall Z-1181-2021

U.S. FDA — Device Enforcement · United States · 2021-01-29 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1181-2021
Date of alert
2021-01-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Getinge Group Logistics America, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07325710001349
Reported risk: Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.