FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
- Recall number
- Z-1318-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
- Status
- Terminated
- Initiated
- 2009-01-21
- Posted
- 2009-06-01
- Terminated
- 2009-06-01
- 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
- Lot, serial or model codes
- Serial numbers 10102, 10103, 10105, and 10106
- 510(k) numbers
- K042095
- PMA numbers
- not on file
- Product code
- JAQ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28