FDA Medical Device Recalls (openFDA)
Toshiba American Med Sys Inc: Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System
- Recall number
- Z-0061-05
- Recalling firm
- Toshiba American Med Sys Inc
- Product
- Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
- Status
- Terminated
- Initiated
- 2004-09-16
- Posted
- 2004-11-02
- Terminated
- 2005-07-13
- Reason
- Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.
- Root cause
- Other
- Action
- Firm issued a letter to users on 9/29/2004 which includes a method to avoid the software problem until it can be corrected by an update.
- Quantity
- 22
- Distribution
- PA, MD, FL, OH, NY, CA, AR, KY, OK, AZ, TX, NV, IN.
- Lot, serial or model codes
- Serial numbers: A4512006, A452017, A4532011, A3612004, A4532014, A4572020, A4572021, A3622005, A4562003, A3592003, A4562018, A4522008, A4532010, A4542015, A4532013, A3622001, A3582001, A4522009, A4532012, A3592002, A4522007, A4552016.
- 510(k) numbers
- ["K032490"]
- 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