OrganOx metra for liver transplant

Regulatory information

OrganOx metra is a CE‑marked class IIa medical device.

The following manufacturer field safety notices for this device have been identified:

Field Safety Notice Reference 2021/006/016/291/001. OrganOx Ltd issued a Field Safety Corrective Action for the OrganOx metra Retained Unit (P/N D0003), affecting all serial numbers in the fleet. An erroneous electrical noise caused battery discharge and recharge issues with a risk of premature device failure. Because of this a design change was implemented and field corrections arranged.