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U.S. Department of Health and Human Services

Class 2 Device Recall Puritan Bennett 560 Ventilator

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  Class 2 Device Recall Puritan Bennett 560 Ventilator see related information
Date Initiated by Firm August 19, 2022
Date Posted September 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-1775-2022
Recall Event ID 90766
Product Classification Continuous ventilator - Product Code QOS
Product Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Code Information UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Technical Support
800-255-6774
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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