PlainRecordsFDA · Medical device recall
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE… and 2 more products
- Date
- Dec. 5, 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
- 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.
- Distribution pattern
- Nationwide distribution
3 products in this recall
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo…
- Product
- GE Healthcare Optima XR 220amx 30kw 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).
- Quantity
- 217 total Installed in the US
- Codes and lots
- Model No - 5555000-5
- Recall started
- Aug. 1, 2012
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0448-2013
GE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo…
- 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).
- Quantity
- 217 total Installed in the US
- Codes and lots
- Model No - 5555000-6
- Recall started
- Aug. 1, 2012
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0449-2013
GE Healthcare Optima XR 200 amx with Digital Upgrade…
- Product
- GE Healthcare Optima XR 200 amx with Digital Upgrade. 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).
- Quantity
- 217 total installed in the US
- Codes and lots
- Model No - 5421698
- Recall started
- Aug. 1, 2012
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- 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.
- Recall number
- Z-0450-2013
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0448-2013, Z-0449-2013, Z-0450-2013. The agency record governs; check it and the company before acting.