medical Class II Updated 2024-11-27

OrganOx Ltd recalls OrganOx metra -Intended as a Normothermic Machine Perfusion

Recalled Product

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 to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.

Hazard / Issue

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

Issued by

FDA

Affected States: DC
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
View official government recall

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