Jul

2012

Cl ll GE Optima Mobile X-ray System

Company:GE Healthcare
Date of Enforcement Report 7/25/12
Class ll:

PRODUCT
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Recall Number Z-1993-2012

REASON
GE Healthcare hos become aware of o software issue on the interfoce of the mobile radiogrophic product, Optima XR200amx, ond Optima XR22Oamx reloted to Visual indicotion as mandoted by the US Code of Federol Regulations (21CFR) and IEC 60601-1-3.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI on 4/4/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
254 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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Cl ll GE Optima Mobile X-ray System

Amy Sellers

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