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Recall Observatory FDA recall evidence

Device product

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

Z-1775-2022

August 19, 2022

Class II

Product summary

Firm
Covidien Llc
Event
Event 90766
Status
Ongoing
Classification
Class II
Quantity
5 US
Official record key
device-enforcement:Z-1775-2022

Official wording

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.

Code information: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error