Mar

2013

Cl ll GE Healthcare Definium 5000 xray Systems

Company:GE Healthcare, LLC
Date of Enforcement Report 3/6/2013
Class ll:

PRODUCT

GE Healthcare Definium 5000 / 5220493 X-Ray System This expected use for this product is intended to take diagnostic radiographic exposures of the skull, spinal column, chest, extremities, abdomen and other body parts.
Recall Number Z-0703-2013 and Z-0704-2013

REASON
It was discovered GE Healthcare had become aware of a software issue associated with the user interface of Definium 5000.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WA on 9/26/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
312 installed in US

DISTRIBUTION
Nationwide

___________________________________

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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Cl ll GE Healthcare Definium 5000 xray Systems

Amy Sellers

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