FDA recall Z-0348-2022

Product

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

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.

Key facts

Status

Terminated

Initiation date

2021-11-04

Report date

2021-12-15

Termination date

2024-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0348-2022