Puritan Bennett 560 Ventilator, PB560, CFN 4096600

FDA device recall Z-1775-2022 · posted 2022-09-22 · Open, Classified

Recall details

Recalling firm

Covidien Llc

Reason for recall

Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.

Action taken

Consignees were notified by letter delivered beginning August 19, 2022. Medtronic is advising that continued use of PB560 ventilators is appropriate when the actions listed in the recall letter are taken into consideration, unless this continued use is inconsistent with facility internal policies and procedures. All affected units require turbine replacement. Customers should contact Medtronic Service at 1-800-255-6774 to arrange for required service to replace the affected ventilator turbine component. If you have any questions regarding this communication, please contact your Medtronic representative or Technical Service at 1-800-255-6774.

Root cause

Process control

Status

Open, Classified

Product code

QOS

Quantity affected

5 US

Distribution

Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.

Date initiated

2022-08-19

Date posted

2022-09-22

Location

Mansfield, MA