Recall Z-1959-2011 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system
| Date | Apr 12, 2011 (initiated Feb 17, 2011) |
| Status | Terminated |
| Reason | During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect |
| Root cause | Other |
| Action | The firm, SIEMENS, sent a "Safety Advisory Notice" dated February 15, 2011 to the affected customers via Update Instructions XP016/10/S on February 17, 2011. The notice described the product, problem and actions to be taken. The customers were instructed to immediately instruct their personnel accordingly; ensure that the safety advisory is placed in the systems's instructions for use; if they have sold this device/equipment and it is no longer in their possession, forward this safety notice to the new owner of the device/equipment; inform SIEMENS about the new owner of the device/equipment, |
| Quantity | 101 |
| Distribution | Nationwide Distribution: USA including states of: AZ, AK, CA, CO, FL, GA. IL, IN, IA, KS, KY, ME, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, and WI. |
| FDA record | Open on fda.gov |