Recall Z-1318-2009 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Siemens Medical Solutions USA, Inc
Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
| Date | Jun 1, 2009 (initiated Jan 21, 2009) |
| Status | Terminated |
| Reason | Table may unintentionally lift during procedure |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009. |
| Quantity | 4 units |
| Distribution | USA distribution to IL, NY, SC, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042095 | MAMMOTEST Fischer Imaging Corp., Oct 29, 2004 |