Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
FDA device recall Z-0138-06 · posted 2005-11-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 16 units
- Distribution
- The product was shipped to medical facilities in CA, FL, IL, MD, MN, NM, OH, OR, RI, and WI.
- Date initiated
- 2005-10-05
- Date posted
- 2005-11-15
- Date terminated
- 2007-08-07
- Location
- Malvern, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS (K010773) | Siemens Medical Solutions USA, Inc. | 2001-05-30 |