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Recall Observatory FDA recall evidence

Device 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.

Z-0501-2025

October 15, 2024

Class II

Product summary

Firm
OrganOx Ltd
Event
Event 95581
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-0501-2025

Official wording

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

Code information: 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

Distribution pattern: California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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

Field note

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