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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Brivo XR385 DRF/ XRay System

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 Class 2 Device Recall GE Healthcare Brivo XR385 DRF/ XRay Systemsee related information
Date Initiated by FirmAugust 03, 2012
Date PostedFebruary 26, 2013
Recall Status1 Terminated 3 on December 05, 2013
Recall NumberZ-0761-2013
Recall Event ID 64226
Product Classification X-ray controls - radiographic - Product Code JAC
ProductGE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Code Information Model Number : 5271997
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionGE Healthcare will, without charge, remedy the issue or bring the product into compliance with each applicable Federal and IEC standard in accordance with a planto be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the software on the system to address the issue. Contact Call Center phone number: 800-437-1171 (United States). For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification
Quantity in Commerce9 units installed in US
DistributionNationwide Distribution including NM, WY, FL, MO, MA, and MI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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