22

Aug

2007

Cl II GE Healthcare

0

Company:GE Healthcare
Date of Enforcement Report:8/21/2007
Class:ll

PRODUCT
a) GE Medical Systems Mac-Lab System, cardiac catheterization data system.
Software Version 6.5 2021423-015 Revision D GE, Recall # Z-1132-2007;
b) GE Medical Systems CardioLab System, electrophysiological data system,
Software Version 6.5 2021423-016 Revision D GE, Recall # Z-1133-2007;
c) GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System,
Software Version 6.5 2021423-015 Revision D and CardioLab System,
Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems, Recall # Z-1134-2007p>
REASON
GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application’s log and imaging windows.

RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letters dated February 16, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2909 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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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