FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Siemens Medical Solutions USA, Malvern PA, 19355
- Recall number
- Z-1048-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, 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
- 35 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: 14001, 14087, 14101, 14182, 14184, 14186, 14206, 14220, 14235, 14236, 14238, 14247, 14252, 14264, 14272, 14276, 14278, 14312, 14334, 14344, 14357, 14359, 14360, 14362, 14268, 14427, 14424, 14427, 14430, 14431, 14434, 14436, 14438, 14443, and 14447.
- 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