PlainRecordsFDA · Medical device recall
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx and 2 more products
- Date
- May 6, 2015
- 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
- Reason
- An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
- Distribution pattern
- US Distribution to the states of: AZ, FL, GA, MO and WI.
3 products in this recall
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
- Quantity
- 6 units US
- Codes and lots
- BrivoXR285amx - PN 5555000, 5555000-2
- Recall started
- Dec. 19, 2014
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.
- Recall number
- Z-1405-2015
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR200 amx
- Quantity
- 6 units in US
- Codes and lots
- OptimaXR200amx PN 5555000-3, PN5555000-4
- Recall started
- Dec. 19, 2014
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.
- Recall number
- Z-1406-2015
GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
- Product
- GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
- Quantity
- 6 units in US
- Codes and lots
- OptimaXR220amx PN 5555000-5, PN5555000-6
- Recall started
- Dec. 19, 2014
- Device type
- System, X-Ray, Mobile
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Healthcare planned action: 1. The customer notification letter will be distributed to the facilities that have installed the following AMX series X-ray systems: Models Brivo XR285 AMX, Optima XR200 AMX, and Optima XR220 AMX. 2. As stated in the customer notification letter, the correction will be provided free of charge and subsequent communication between the firm and the facility will result in a site visit by a GE Healthcare field engineer to bring the X-ray system into compliance. 3. The GEHC field engineer will follow Field Modification Instruction 10899 which provides instructions on how to perform a mAs accuracy check and how to determine if the test results pass predetermined acceptance criteria. If you have any questions or concerns regarding this notification, please call the Information following phone number: 1-800-437-1171.
- Recall number
- Z-1407-2015
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1405-2015, Z-1406-2015, Z-1407-2015. The agency record governs; check it and the company before acting.