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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare

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  Class 2 Device Recall GE Healthcare see related information
Date Initiated by Firm August 01, 2012
Date Posted November 29, 2012
Recall Status1 Terminated 3 on January 10, 2013
Recall Number Z-0449-2013
Recall Event ID 63212
Product Classification System, x-ray, mobile - Product Code IZL
Product GE Healthcare Optima XR 220amx 15kw 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).
Code Information Model No - 5555000-6
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 mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action GE Healthcare will without charge remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication through a GE Healthcare field engineer site visit. Field Modification Instructions (FMI) 10868 describes the rework plan the GEHC Engineers will make to the imaging system compliant with the applicable performance standard. This CAP appears to adequately address the problem and is hereby approved. 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 Commerce 217 total Installed in the US
Distribution Nationwide distribution
Total Product Life Cycle TPLC 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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