Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling Puritan Bennett 980 Series Ventilators (model 980U1ENASAA) due to a manufacturing assembly error involving an incorrectly assembled capacitor. This defect may cause the ventilator to stop working during use. The recall affects 278 devices that were distributed worldwide and throughout the US, identified by specific serial numbers beginning with 35B1700.
The recall source does not specify a remedy or what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Reason for recall: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Distribution: Worldwide distribution - US Nationwide. Quantity: 278 total Lot/code info: GTIN/UDI - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.