FDA Medical Device Recalls (openFDA)
Covidien Llc: Puritan Bennett 560 Ventilator, PB560, CFN 4096600
- Recall number
- Z-1775-2022
- Recalling firm
- Covidien Llc
- Product
- Puritan Bennett 560 Ventilator, PB560, CFN 4096600
- Status
- Open, Classified
- Initiated
- 2022-08-19
- Posted
- 2022-09-22
- Terminated
- not on file
- Reason
- 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
- 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
- 5 US
- Distribution
- Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
- Lot, serial or model codes
- UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QOS
- Firm FEI
- 3002807850
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28