PlainRecordsFDA · Medical device recall
Optima XR220amx Mobile general purpose radiographic imaging of the… and 1 more product
- Date
- Sept. 19, 2012
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- GE Healthcare, LLC
- Reason
- 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.
- Distribution pattern
- Worldwide Distribution -- USA (nationwide) Distribution
2 products in this recall
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body
- Product
- Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
- Quantity
- 254 total in the US
- Codes and lots
- Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
- Recall started
- July 10, 2012
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-2255-2012
Optima XR200amx…
- Product
- Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
- Quantity
- 254 total in the US
- Codes and lots
- Part Numbers: 5555000-3, 5555000-4, 5555000-5, 5555000-6.
- Recall started
- July 10, 2012
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-2256-2012
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2255-2012, Z-2256-2012. The agency record governs; check it and the company before acting.