Recalls / —
—#80301
Product
Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
- FDA product code
- JAQ — System, Applicator, Radionuclide, Remote-Controlled
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K042095
- Affected lot / code info
- Serial numbers 10102, 10103, 10105, and 10106
Why it was recalled
Table may unintentionally lift during procedure
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- USA distribution to IL, NY, SC, and WA
Timeline
- Recall initiated
- 2009-01-21
- Posted by FDA
- 2009-06-01
- Terminated
- 2009-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #80301. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.