FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
- Recall number
- Z-0546-04
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models.
- Status
- Terminated
- Initiated
- 2004-01-27
- Posted
- 2004-07-20
- Terminated
- 2005-07-13
- Reason
- Software anomally causes image slices to be in incorrect order.
- Root cause
- Other
- Action
- Firm sent letters to customers 1/28/2004 which explains how to avoid the adverse event and announces that a software fix is going to be made available.
- Quantity
- 24
- Distribution
- NV, CO, OH, PA, CA, TN, FL, TX, OK, OR, NY, NJ and Puerto Rico.
- Lot, serial or model codes
- Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with softare V4.04*R251 to V4.10*R271.
- 510(k) numbers
- ["K933018","K961092","K990620"]
- 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