Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Puritan Bennett 980X1ENNISB ventilator due to a manufacturing assembly error involving an incorrectly assembled capacitor. This defect may cause the ventilator to become inoperable during use. A total of 278 units were distributed worldwide, including throughout the United States.
The affected ventilators have GTIN/UDI 10884521171749 and specific serial numbers ranging from 35B1700430 to 35B1700608. The recall source does not specify a remedy or corrective action for consumers.
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 - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.