COVIDIEN Recalls Puritan Bennett 980 Ventilators Due to Software Update Issues
COVIDIEN LLC is recalling 9,593 Puritan Bennett 980 ventilators worldwide due to a software update affecting external USB drive performance and GUI functionality.
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 recall is classified as FDA Class I, which per the rubric mandates a minimum severity score of 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
COVIDIEN LLC is recalling 9,593 units of the Puritan Bennett 980 (PB980) ventilator series, including Pediatric, Adult, Neonatal, and Universal models. The recall is due to a software update that impacts the performance of external USB drives and the labeling of the scalar waveform displayed on the Graphic User Interface (GUI) during ventilation.
The affected devices are distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, Africa, and the Middle East. The ventilators are designed for use on patient populations from neonatal through adult who require respiratory support or mechanical ventilation.
Healthcare facilities should contact COVIDIEN LLC for instructions on how to resolve the software issue. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient…
- Manufacturer
- COVIDIEN LLC
- Category
- Medical Device — Ventilator
- Affected units
- 9,593
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 (8)
- 35B1601183
- 35B1601193
- 35B1601197
- 35B1601242 35B1601243
- 35B1601245
- 35B1702479
- 35B1601001
- 35B1601089
Distribution
Distributed nationwide across the United States.
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Similar recalls
- SevereFDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue
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