Recall Z-1942-2013 ยท IZL System, X-Ray, Mobile
GE Healthcare, LLC
GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body pants with the patient sitting, standing, or lying in the p
| Date | Aug 9, 2013 (initiated Aug 7, 2012) |
| Status | Terminated |
| Reason | GE Healthcare conducted a recall on various mobile x-ray units (Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems) because of an Erratic Drive Performance. |
| Root cause | Software design |
| Action | GE Healthcare recall strategy was to update all of the affected Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems that were distributed. At this time ( 2/14/2013), deployment of this recall is considered complete. Should you have any questions or require additional information, please contact Regulatory Affairs Leader by telephone at 262-548-2198 or email paulcorrigan@ge.com |
| Quantity | 458 (306 US; 152 OUS) |
| Distribution | Worldwide distribution: USA (nationwide) including states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, GUAM, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, NV, NH, NH, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY; and countries of: Albania, Australia, Bahrain, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX Ge Medical Systems, LLC, Jun 16, 2011 |