FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.
- Recall number
- Z-0937-04
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems.
- Status
- Terminated
- Initiated
- 2004-05-06
- Posted
- 2004-07-20
- Terminated
- 2005-03-15
- Reason
- Software anomaly.
- Root cause
- Other
- Action
- Firm will send letters followed by visits to install software repair.
- Quantity
- 50
- Distribution
- Nationwide.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K933018","K961092","K990620","K993803","K002531"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2020563
- Firm city
- Tustin
- Firm state
- CA
- 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