FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Magnetom Symphony MRI System, Model 7104594
- Recall number
- Z-1399-04
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Magnetom Symphony MRI System, Model 7104594
- Status
- Terminated
- Initiated
- 2004-07-28
- Posted
- 2004-08-24
- Terminated
- 2005-01-25
- Reason
- An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Root cause
- Other
- Action
- The recalling firm issued a Customer Safety Advisory letter via certified mail to their customers per Update Instructions MR028/04/S. The letter informs customers of the potential issue and provides instructions to avoid its occurence.
- Quantity
- 3 units
- Distribution
- The products were shipped to 39 medical facilities in CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, and VA.
- Lot, serial or model codes
- Serial numbers 22009, 22016, and 22081
- 510(k) numbers
- ["K971684"]
- 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