FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: MR Systems
- Recall number
- Z-1087-03
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- MR Systems
- Status
- Terminated
- Initiated
- 2003-02-28
- Posted
- 2003-08-07
- Terminated
- 2004-12-23
- Reason
- software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
- Root cause
- Other
- Action
- The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.
- Quantity
- 1374 units
- Distribution
- The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
- Lot, serial or model codes
- Upgrade Harmony Syngo MR, model 7106714 K2200 Serial # 10501 through 10587. Harmony Syngo MR, model 7104693 K2200 Serial # 11001 through 11172. Upgrade Symphony Syngo MR, model 7106557 K 2210 Serial # 14001 through 14321. IMPACT - Upgrade Syngo MR (MU3S), model 5751438 K2220 Serial # 15001 through 15030. IMPACT - Upgrade Syngo MR (MU3L), model 7106466 K2220 Serial # 15501 through 15519. VISION - Upgrade Quantum, model 4772971 K2230 Serial # 16001 through 16017. VISION - Upgrade Sonata, model 7388148 K2230 Serial # 16501 through 16513. Concerto Upgrade, model 7106995 K2221 Serial # 17201 through 17211. Concerto, model 4772906 K2221 Serial #17301 through 17473. Syngo Allegra, model 7106433 K2183 Serial #20101 through 20110. Upgrade Allegra syngo MR, model 7387736 K2183 Serial # 20401 through 20421. Trio (Bruker), model 7106441 K2180 Serial #20500 through 20507. Trio, model 7387074 K2180 Serial #20510 through 20524 and 20550 through 20552. Sonata Syngo MR, model 7104719 K2240 Serial #21101 through 21248. Syngo MR SYM-Sonata-Upgrade, model 7104735 K2240 Serial #21604 through 21612. Syngo MR Upgrade Sonata, model 7106425 K2240 Serial #21901 through 21942. Symphony syngo MR, model 7104594 K2210 Serial 22001 through 22996. Rhapsody, model 7384568 K2190 Serial #24001 through 24004.
- 510(k) numbers
- ["K020991","K003628"]
- 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