Moderate FDA (Devices)·Z-0180-2015·Announced 2014-12-17

Covidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure

Nellcor Puritan Bennett is recalling 324 Puritan Bennett 980 Ventilators because a capacitor component can fail, causing a dim screen and thermal odor.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The described symptoms (dim screen, thermal odor) do not indicate immediate serious injury or death, fitting the criteria for a moderate severity score.

Plain-English summary

Nellcor Puritan Bennett Inc. (dba Covidien LP) is recalling 324 units of the Puritan Bennett 980 Ventilator System. The recall is due to a defect in the blacklight inverter PCBA where a capacitor component can fail.

This failure can cause the device screen to become dim, though it remains functional, and may produce a thermal odor. The affected units were distributed worldwide, including in the United States, Canada, Mexico, Saudi Arabia, South Africa, and the United Arab Emirates.

Healthcare facilities and users should check their inventory for the specific model numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to the manufacturer for repair or replacement.

The recalled product

Product: Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Manufacturer: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Category: Medical Device — Ventilator
Hazard: component-failure
thermal-odor
Affected units: 324

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model number PB980 Ventilator:35B1400143
35B1400684
35B1400627
35B1400708
35B1400398
35B1400482
35B1400491
35B1400512
35B1400601
35B1400121
35B1400568
35B1400590
35B1400595
35B1400599
35B1400606
35B1400106
35B1400146
35B1400169
35B1400226
35B1400260

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Same manufacturer · Nellcor Puritan Bennett Inc. (dba Covidien LP)

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Same hazard · component failure