Puritan Bennett 980 Series Ventilator recalled for assembly defect
Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.
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: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. A capacitor assembly defect causing ventilator inoperability during use poses a serious patient safety risk, as ventilators are life-critical medical equipment. No deaths or injuries have been reported in the source text.
Plain-English summary
The Puritan Bennett 980 Series Ventilator, model 980X1JADIJJ, manufactured by Covidien LLC, is being recalled by the FDA. The recall affects 278 units that were distributed worldwide, including to medical facilities throughout the United States.
A manufacturing assembly error in the ventilator's capacitor may cause the device to become inoperable during use. Ventilators are critical life-support equipment, and device failure during patient use poses a serious risk to patient safety.
If you have one of the affected ventilators, stop using it immediately and contact Covidien LLC. The FDA recall notice identifies the specific serial numbers and product codes for affected units. Healthcare facilities should review their equipment inventories and discontinue use of any matching ventilators.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
- 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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