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U.S. Department of Health and Human Services

Class 2 Device Recall OrganOX metra

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 Class 2 Device Recall OrganOX metrasee related information
Date Initiated by FirmOctober 15, 2024
Date PostedNovember 21, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0501-2025
Recall Event ID 95581
PMA NumberP200035 
Product Classification Normothermic machine perfusion system for the preservation of donor livers prior to transplantation - Product Code QQK
ProductOrganOx 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.
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
FEI Number 3011560054
Recalling Firm/
Manufacturer		 OrganOx Ltd
Magdalen Centre
1 Robert Robinson Avenue
Oxford United Kingdom
For Additional Information ContactJeff Fecho
973-5544393
Manufacturer Reason
for Recall		Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
FDA Determined
Cause 2		Device Design
ActionOrganOx 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
Quantity in Commerce20 units
DistributionCalifornia, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma, DC, South Carolina and Georgia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = QQK
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