Recall Z-0138-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Siemens Medical Solutions USA, Inc
Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
| Date | Nov 15, 2005 (initiated Oct 5, 2005) |
| Status | Terminated |
| Reason | If the recommended workflow is not followed and the worksheets are printed after moving the patient table out of isocenter, the offset values will be incorrect. This could result in a biopsy being performed at an incorrect location and presents the possibility of an inconclusive diagnosis. calculation of offset values for the breast biopsy aiming device may be incorrect |
| Root cause | Other |
| Action | The recalling firm issued a Customer Safety Advisory via certified mail to affected customers per Update Instructions MR034/05/S. The letter re-emphasizes the importance of printing the offset values on the worksheet prior to moving the patient table and in accordance with the User's Manual. |
| Quantity | 16 units |
| Distribution | The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010773 | BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS Siemens Medical Solutions USA, Inc., May 30, 2001 |