14
Dec
2016

SynCardia 5000 Series Freedom Drivers Cl II

0

Company: SynCardia Systems Inc.
Date of Enforcement Report 12/14/2016
Class lI:

PRODUCT

5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Recall Number Z-0659-2017

REASON
The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause the Freedom Driver to stop functioning without visual or audible alarms, resulting in the loss of life-sustaining function.

RECALLING FIRM/MANUFACTURER
SynCardia Systems Inc., tuscon, AZ on 10/21/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
5

DISTRIBUTION
US distribution to Virginia and Arizona.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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