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[Recalled] Puritan Bennett 980 Series Ventilator, 980S1ENDICU — Manufacturing assembly error where a capacitor within the ventilator was assemb… | FDA 2021-11-04

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductPuritan Bennett 980 Series Ventilator, 980S1ENDICU
Brand / manufacturerCovidien Llc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0340-2022
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date04 November 2021
EAN / barcode10884521171114

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Covidien Llc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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