Z-0501-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2024
- Initiation Date
- October 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
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.
Reason for Recall
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Distribution Pattern
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
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