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.
This recall is currently active, issued November 21, 2024.
- Recall Initiated
- October 15, 2024
- Posted
- November 21, 2024
- Recall Number
- Z-0501-2025
- Quantity
- 20 units
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Device Design
Action Taken
OrganOx issued Important Field Correction Notice letter on 10/15/24 via Fed'X. letter states reason for recall, health risk and action to take: As a result of the investigation into this event, OrganOx has implemented a secondary battery retention mechanism to prevent battery movement due to jarring or impact that could be related to machine transport or movement. The secondary battery retention mechanism will be installed on your machine by OrganOx service personnel no later than 15 December 2024. Recommendations: The metra in your possession continues to be safe and effective in anticipation of this correction and the machine may be used as normal. Should an unexpected rapid decrease in battery voltage occur as noted by alarm from the metra, please determine the impact to the perfusion event and take action if needed. Should this occur, please follow the OrganOx complaints reporting process and quarantine the machine until it can be serviced. Should you have questions about this important Field Correction please contact: Michael Donahue Michael.donahue@organox.com +1 732-948-2175