—#135537

Product

GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K142383
Affected lot / code info: OptimaXR220amx PN 5555000-5, PN5555000-6

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Distribution to the states of: AZ, FL, GA, MO and WI.

Timeline

Recall initiated: 2014-12-19
Posted by FDA: 2015-04-27
Terminated: 2015-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.