Agency classClass IOur severity:Severe FDA (Devices)·Z-0112-2015·Announced 2014-11-05

FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

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 classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 324 units of the Covidien Puritan Bennett 980 Ventilator. The recall is due to a software issue that may lead to the ventilator becoming inoperative. The devices are prescription-only and are suitable for service in hospitals and for intra-hospital transport to provide continuous positive pressure ventilation for neonatal through adult patient populations.

The affected units were distributed worldwide, including in the United States (specifically in CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI) and in Canada, Mexico, Saudi Arabia, South Africa, and the United Arab Emirates. The recall covers specific model numbers listed in the agency's documentation.

Hospitals and healthcare institutions should contact Nellcor Puritan Bennett Inc. (dba Covidien LP) for instructions on how to address the software issue. The FDA classifies this as a Class I recall, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

Product: Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Manufacturer: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Category: Medical Device — Ventilator
Hazard: device-malfunction
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 in 17 states:

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

See all →

Severe
Covidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
FDA (Devices) · 2014-12-17
Moderate
Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch
FDA (Devices) · 2014-08-20
High
Vital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch
FDA (Devices) · 2014-08-20
High
Puritan Bennett 840 Ventilator Recall for Display Loss
FDA (Devices) · 2014-07-02
High
Nellcor Puritan Bennett PB840 Ventilator Display Component Recalled
FDA (Devices) · 2014-06-25

Same hazard · device malfunction