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

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU — recall Z-0347-2022

U.S. FDA — Device Enforcement · United States · 2021-11-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0347-2022
Date of alert
2021-11-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Covidien Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521171541
Reported risk: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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.

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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.