FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
- Recall number
- Z-0138-06
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
- Status
- Terminated
- Initiated
- 2005-10-05
- Posted
- 2005-11-15
- Terminated
- 2007-08-07
- 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.
- Lot, serial or model codes
- Model number 5728735
- 510(k) numbers
- ["K010773"]
- PMA numbers
- not on file
- Product code
- LNH
- 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