Date Initiated by Firm | September 20, 2012 |
Date Posted | November 16, 2012 |
Recall Status1 |
Terminated 3 on December 05, 2013 |
Recall Number | Z-0200-2013 |
Recall Event ID |
63597 |
Product Classification |
Image-intensified fluoroscopic x-ray system mobile - Product Code OXO
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Product | GE Healthcare Brivo XR 285
Mobile general purpose radiographic imaging of the human head and body. |
Code Information |
part numbers:5555000, 5555000-2 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-513-4122 |
Manufacturer Reason for Recall | It was discovered GE Healthcare has become aware of a firmware issue on the mobile radiographic product, Brivo XR285amx, Optima XR200amx, Optima XR22Oamx and Optima XR200amx with Digital Upgrade, related to Technique Accuracy as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-2-54. |
FDA Determined Cause 2 | Radiation Control for Health and Safety Act |
Action | GE Healthcare will remedy the defect or bring the product into compliance with each applicable Federal and IEC standard. A Service Representative will update the firmware on the system to address the issue.
Field Modification Instructions (FMI) 10870, 10872, and 10873 are describing the rework plan the GEHC Engineers will make to the imaging systems compliant with the applicable performance standard.
Further questions please call (262) 513-4122. |
Quantity in Commerce | 364 total units installed in US |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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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