Recall Z-0929-2009 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Somatom Definition AS, Model number 8098027. Computed tomography x-ray system
| Date | Jan 23, 2009 (initiated Dec 9, 2008) |
| Status | Terminated |
| Reason | possible improper installation of tilt transport lock/tilt limiter |
| Root cause | Labeling Change Control |
| Action | The recalling firm received a letter dated 11/25/08 from the manufacturer informing them of the problem. As a result, the recalling firm has issued Update Instruction CT065/08/S to have the transport lock/tilt limiter on the device visually inspected. The tilted scan modes have been disabled until the modified lock/tilt limiter has been installed. |
| Quantity | 42 units |
| Distribution | Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081022 | SOMATOM DEFINITION, MODEL AS/AS+ Siemens Medical Solutions USA, Inc., Jun 2, 2008 |