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FDA (Device enforcement)Recalled 2024-10-15class ii

OrganOx Ltd: OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used t

Hazard

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Details from the source

Reason for recall: Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket Distribution: California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia. Quantity: 20 units Lot/code info: UDI-DI: 05060462240029 Serial numbers 511, 512, 514, 515, 516, 517, 518, 519, 520, 522, 523, 524, 525, 527, 528, 529, 530, 531, 533, 535, 536, 537

UPC codes

05060462240029

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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