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