GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
FDA device recall Z-1405-2015 · posted 2015-04-27 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 6 units US
- Distribution
- US Distribution to the states of: AZ, FL, GA, MO and WI.
- Date initiated
- 2014-12-19
- Date posted
- 2015-04-27
- Date terminated
- 2015-04-29
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX (K103476) | Ge Medical Systems, LLC | 2011-06-16 |