Recall Z-1421-2011 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Siemens Medical Solutions USA, Inc
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
| Date | Feb 23, 2011 (initiated Jan 14, 2011) |
| Status | Terminated |
| Reason | Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing |
| Root cause | Other |
| Action | Siemens Medical Solutions USA, Inc issued a Customer Safety Advisory Notice via Update Instruction XP005/10/S to affected customers. This letter informs customers of the potential malfunction and of possible danger for patients, users or other persons. A future Update Instruction will be released for the replacement of the tilt buttons on all OPTI Grip handles. Customers were instructed to forward the safety notice to any new owners of this device and to provide Siemens Medical with names of the new customers. For any questions regarding this recall call 610-448-3237. |
| Quantity | 1323 |
| Distribution | Nationwide Distribution including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. |
| FDA record | Open on fda.gov |