Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling 278 Puritan Bennett 980 Series ventilators (model 980S1ENDICU) worldwide, including units distributed across the United States. The ventilators are being recalled due to a manufacturing assembly error in which a capacitor was incorrectly assembled inside the device. This defect may cause the ventilator to become inoperable during use. The affected units can be identified by the GTIN/UDI 10884521171114 and the following serial numbers: 35B1700409, 35B1700443, 35B1700457, 35B1700462, 35B1700473, 35B1700476, 35B1700483, 35B1700487, 35B1700490, 35B1700511, 35B1700552, 35B1700567, 35B1700569, and 35B1700570.
The recall notice does not specify a remedy or corrective action for consumers to 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 - 10884521171114 Serial Numbers: 35B1700409 35B1700443 35B1700457 35B1700462 35B1700473 35B1700476 35B1700483 35B1700487 35B1700490 35B1700511 35B1700552 35B1700567 35B1700569 35B1700570
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.