FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165
- Recall number
- Z-1529-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165
- Status
- Terminated
- Initiated
- 2005-08-12
- Posted
- 2005-09-09
- Terminated
- 2006-07-19
- Reason
- there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore
- Root cause
- Other
- Action
- The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.
- Quantity
- 209 units
- Distribution
- The products were shipped to medical facilities and MRI facilities nationwide.
- Lot, serial or model codes
- Serial numbers 30001 to 30075
- 510(k) numbers
- ["K041112"]
- PMA numbers
- not on file
- Product code
- LNN
- 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