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U.S. Department of Health and Human Services

Class 2 Device Recall Optima

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  Class 2 Device Recall Optima see related information
Date Initiated by Firm July 10, 2012
Date Posted September 13, 2012
Recall Status1 Terminated 3 on January 10, 2013
Recall Number Z-2256-2012
Recall Event ID 62946
Product Classification System, x-ray, mobile - Product Code IZL
Product Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Code Information Part Numbers: 5555000-3, 5555000-4, 5555000-5, 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		 Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action The firm will issue Important Electronic Product Radiation Warning letters that identify the affected product along with a description of the defect and related hazards. Users are instructed to ensure that the acquisition mode is always selected prior to attempting an exposure to confirm the techniques selected. The firm will remedy the issue or bring the device into compliance free of charge. A GE Healthcare Service Representative will update the software on the system to address the issue. Field Modification Instructions (FMI) 10865(2) describes the rework plan the GEHC Engineers will make to the imaging system to return it to compliance with the applicable performance standard. It appears to adequately address the problem and is hereby approved. Users are to contact 800-437-1171 in the US, if they have any questions or concerns.
Quantity in Commerce 254 total in the US
Distribution Worldwide Distribution -- USA (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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