Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
FDA device recall Z-1318-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Table may unintentionally lift during procedure
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 4 units
- Distribution
- USA distribution to IL, NY, SC, and WA
- Date initiated
- 2009-01-21
- Date posted
- 2009-06-01
- Date terminated
- 2009-06-01
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAMMOTEST (K042095) | Fischer Imaging Corp. | 2004-10-29 |