Z-1775-2022Class II

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

Name: Z-1775-2022 Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Creator: Covidien Llc
Published: 2022-08-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-08-19 / Open, Classified / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Puritan Bennett 560 Ventilator, PB560, CFN 4096600 on 2022-08-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1775-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-19
Posted: 2022-09-22
Recalling firm: Medtronic, Inc.
Product: Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Product code: QOS Continuous Ventilator
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 5 US
Distribution: Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
Product codes and lots: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1775-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-28	2022-09-22

Product code QOS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)