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.
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. Distribution: Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide. Quantity: 5 US Lot/code info: UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340
10884521196377
Official record: FDA (Device enforcement) ↗
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