Recall Z-1675-2009 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system
| Date | Jul 30, 2009 (initiated May 29, 2009) |
| Status | Terminated |
| Reason | Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury. |
| Root cause | Equipment maintenance |
| Action | The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems. |
| Quantity | 93 units |
| Distribution | Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, 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 |