Puritan Bennett 980 Ventilator recalled for capacitor assembly defect
The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.
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: FDA Class I classification means this recall cannot be scored below 4 (Severe) per regulatory guidelines. Although no adverse events are reported in the source text, the risk of device inoperability during use in a critical medical application constitutes a serious health hazard.
Plain-English summary
Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator, model 980X1ENNISB. The recall was issued due to a manufacturing assembly error involving an internal capacitor that was installed incorrectly.
A capacitor assembled incorrectly within the ventilator may cause the device to become inoperable during use. This poses a risk to patient safety, particularly in clinical settings where the ventilator is relied upon for respiratory support.
A total of 278 units have been distributed worldwide, including across the United States. The recall affects devices with the following serial numbers: 35B1700430, 35B1700442, 35B1700456, 35B1700510, 35B1700514, 35B1700520, 35B1700553, 35B1700554, 35B1700559, 35B1700561, and 35B1700608.
Patients and healthcare providers who have affected ventilators should contact Covidien Llc or consult the FDA recall notice for instructions on device replacement or repair.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X1ENNISB
- Manufacturer
- Covidien Llc
- Affected units
- 278
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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