Recall Z-0162-2010 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment.
| Date | Nov 10, 2009 (initiated Aug 11, 2009) |
| Status | Terminated |
| Reason | In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly. |
| Root cause | Device Design |
| Action | Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436. |
| Quantity | 3 units |
| Distribution | Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060631 | BIOGRAPH 64 AND BIOGRAPH 40 Siemens Medical Solutions USA, Inc., Mar 17, 2006 |