Recall Z-1399-2012 ยท IZL System, X-Ray, Mobile
GE Healthcare, LLC
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 positio
| Date | Apr 24, 2012 (initiated Dec 23, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| 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 exte |
| Quantity | 130 installed in US |
| Distribution | USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.