Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
Check against the official notice below — it lists the full affected range.
Covidien LLC has recalled 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error involving an incorrectly assembled capacitor. This defect may cause the ventilator to become inoperable during use. The recalled devices were distributed worldwide and throughout the United States, and are identified by GTIN/UDI 10884521171558 and specific serial numbers beginning with 35B1700309 through 35B1800026.
The recall record does not specify a remedy or instructions for affected consumers regarding what action they 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 - 10884521171558 Serial Numbers: 35B1700309 35B1700374 35B1700411 35B1700432 35B1700435 35B1700436 35B1700437 35B1700439 35B1700470 35B1700475 35B1700482 35B1700486 35B1700488 35B1700492 35B1700493 35B1700512 35B1700516 35B1700517 35B1700518 35B1700519 35B1700522 35B1700529 35B1700531 35B1700538 35B1700544 35B1700545 35B1700546 35B1700547 35B1700549 35B1700575 35B1700578 35B1700610 35B1800026
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.