Agency classClass IOur severity:Severe 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor."

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)

See all →

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Moderate
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High
Puritan Bennett 840 Ventilator Recall for Display Loss
FDA (Devices) · 2014-07-02
High
Nellcor Puritan Bennett PB840 Ventilator Display Component Recalled
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Same hazard · component failure