FDA-Device2024-11-27Class II
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.
OrganOx Ltd
Hazard
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Sold states
California, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
Affected count
20 units
Manufactured in
Magdalen Centre, 1 Robert Robinson Avenue, Oxford, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0501-2025Don't want to check this manually?
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