GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pedia
FDA device recall Z-1942-2013 · posted 2013-08-09 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 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,
- Date initiated
- 2012-08-07
- Date posted
- 2013-08-09
- Date terminated
- 2014-02-04
- 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 |