—#195688

Product

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

FDA product code: QOS — Continuous Ventilator
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

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

Timeline

Recall initiated: 2022-08-19
Posted by FDA: 2022-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195688. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.