FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355
- Recall number
- Z-1044-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355
- Status
- Terminated
- Initiated
- 2007-12-01
- Posted
- 2008-03-25
- Terminated
- 2012-10-01
- Reason
- Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.
- Root cause
- Device Design
- Action
- The firm issued an Update Instruction package to consignees 12/07. As an immediate measure, the recalling firm is initiating field checks of mobile MRI systems per Update Instruction MR039/07/S. This update defines a safety inspection for mobile systems, including checks for potential ice formation and proper configuration of venting assemblies.
- Quantity
- 10 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: 11006, 11044, 11065, 11090, 11102, 11112, 11115, 11127, 11157, and 11162.
- 510(k) numbers
- ["K970852"]
- 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