PlainRecordsFDA · Medical device recall
GE Healthcare Optima XR 200amx with digital upgrade Mobile general… and 3 more products
- Date
- Nov. 28, 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
- 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.
- Distribution pattern
- Nationwide Distribution
4 products in this recall
GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human…
- Product
- GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body.
- Quantity
- 364 total units installed in US
- Codes and lots
- part number: 5421698
- Recall started
- Sept. 20, 2012
- Device type
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0197-2013
GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body
- Product
- GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
- Quantity
- 364 total units installed in US
- Codes and lots
- part numbers: 5555000-5, 5555000-6
- Recall started
- Sept. 20, 2012
- Device type
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0198-2013
GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body
- Product
- GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body.
- Quantity
- 364 total units installed in US
- Codes and lots
- part numbers: 5555000-3, 5555000-4
- Recall started
- Sept. 20, 2012
- Device type
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0199-2013
GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body
- Product
- GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body.
- Quantity
- 364 total units installed in US
- Codes and lots
- part numbers:5555000, 5555000-2
- Recall started
- Sept. 20, 2012
- Device type
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0200-2013
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0197-2013, Z-0198-2013, Z-0199-2013, Z-0200-2013. The agency record governs; check it and the company before acting.