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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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