Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error
Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.
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: FDA Class I designation requires minimum severity score of 4. The device has a documented manufacturing defect that may render it inoperable during use. No reported deaths, injuries, or illnesses are documented in the source text.
Plain-English summary
Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator (model 980U1ESDIUC) due to a manufacturing assembly error. The recall affects approximately 278 units distributed worldwide with US nationwide presence, identified by serial numbers 35B1700408, 35B1700412, 35B1700499, and 35B1700525.
The defect involves incorrect assembly of a capacitor within the ventilator. This error may cause the device to become inoperable during use.
Users of affected devices should stop using the ventilator immediately and contact Covidien Llc for instructions on device replacement or repair.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
- 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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