GE Healthcare Automatic Mobile X- Ray (AMX) series: Brivo XR285 15KW, Brivo XR285 30KW, Optima XR200 15KW, Optima XR200 30KW, Optima XR220 15KW, and Optima XR220 30KW. General Electric, Waukesha, WI Indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position.
FDA Recall Z-1399-2012 · Posted 2012-04-24
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIZL
Date Initiated2011-12-23
Date Terminated2014-01-16
Product Quantity130 installed in US
Reason for Recall
GE Healthcare has become aware of a discrepancy on the x-ray source assembly of the mobile radiographic product, related to the light field to x-ray field edge alignment.
Firm Action
GE Healthcare will issue an Important Electronic Product Radiation Warning letter to customers. The letter will describe the defect and related hazards, along with the safety instructions, affected product, and product correction GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal and IEC standard in accordance with an approved plan, the details of which will be included in a subsequent communication to customers or through a GE Healthcare field engineer site visit. A GE Healthcare Service Representative will update the external tube port on the source assembly to address the issue.
Questions or concerns can be directed to the Call Center at 800-437-1171 or your local GE Healthcare Service Representative.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
USA (nationwide)
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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