Recall Z-0348-2022 ยท CBK Ventilator, Continuous, Facility Use
Covidien Llc
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
| Date | Dec 9, 2021 (initiated Nov 4, 2021) |
| Status | Terminated |
| Reason | Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| Root cause | Reprocessing Controls |
| Action | On November 4, 2021, the firm began to notify customers through Urgent Medical Device Correction letters. Customers were informed of the device defect that may lead to the ventilator becoming inoperable during use. Actions you should take Immediately discontinue use of the affected ventilators. Remove the affected ventilators from clinical service and quarantine the affected ventilators until such time that a Medtronic Technical Service Engineer inspects and replaces the affected printed circuit board assemblies. Notify all personnel in all care environments in which the affected PB980 se |
| Quantity | 278 total |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193056 | Puritan Bennett 980 Series Ventilator System Covidien, LLC, Nov 20, 2020 |