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

Recall Z-2596-2021 — Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Config., Aespire 100 Compact Wall Mount (Aespire 7100); (5) S/5 Aespire 7900; (6) Aespire View;

U.S. FDA — Device Enforcement · United States · 2021-08-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2596-2021
Date of alert: 2021-08-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0080682102339

Reported risk: The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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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