Medical Device Recall: 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 susta
OrganOx Ltd · October 15, 2024
Reason for Recall
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
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.
Distribution
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
States Affected
DC
Quantity Affected
20 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0501-2025
Status: ongoing
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