Puritan Bennett 980 Ventilator Batteries Recalled for Firmware Defect
FDA is recalling 15,885 rechargeable lithium-ion batteries for Puritan Bennett 980 ventilators due to incorrect firmware that may prevent full charging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a critical medical device (ventilator) where a power failure could lead to serious harm, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 15,885 units of rechargeable lithium-ion batteries used with the Puritan Bennett 980 Series Ventilator System. The affected batteries, manufactured by Covidien LLC, are intended to provide backup power to the ventilator in case of AC power loss.
The recall is due to incorrect firmware in the batteries, which may prevent them from fully charging after installation. This defect could compromise the ventilator's ability to function as a backup power source during power outages.
The affected batteries were distributed worldwide, including in the United States and numerous international markets. Healthcare facilities and users of these ventilators should check their battery serial numbers against the recall list and contact the manufacturer for instructions on replacement or repair.
The recalled product
- Product
- Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to…
- Manufacturer
- Covidien LLC
- Affected units
- 15,885
Distribution
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