Mar

2013

GE Healthcare Brivo XR385 DR-F/ X-Ray System Cl ll

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

PRODUCT

GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Recall Number Z-0761-2013

REASON
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.

RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WA on 8/32012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 units 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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GE Healthcare Brivo XR385 DR-F/ X-Ray System Cl ll

Amy Sellers

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