05
Dec
2012

Cl ll GE Healthcare Optima XR Mobile X-ray System

0

Company:GE Healthcare LLC
Date of Enforcement Report 12/5/12
Class ll:

PRODUCT

GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). Recall Number Z-0448-2013

REASON
GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.

RECALLING FIRM/MANUFACTURER
GE Healthcare LLC, Waukesha, WI on 8/1/2012 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
217

DISTRIBUTION
Nationwide

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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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