Puritan Bennett 980 Series Ventilator, 980S3ENDICU
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling 278 Puritan Bennett 980 Series ventilators due to a manufacturing assembly error involving a capacitor that was installed incorrectly. This defect may cause the ventilator to stop working during use. The affected devices were distributed worldwide, including throughout the United States, and can be identified by the GTIN/UDI number 10884521171244 or by their serial numbers, which range from 35B1700406 to 35B1700558.
The recall notice does not specify a remedy or instructions for what affected consumers should do.
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 - 10884521171244 Serial Numbers: 35B1700406 35B1700449 35B1700467 35B1700469 35B1700471 35B1700474 35B1700481 35B1700526 35B1700558
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.