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FDA Medical Device Recalls (openFDA)

Toshiba American Med Sys Inc: Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN

Recall number
Z-0273-05
Recalling firm
Toshiba American Med Sys Inc
Product
Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN
Status
Terminated
Initiated
2004-08-24
Posted
2004-12-02
Terminated
2005-09-02
Reason
Software defect causes patient identification number to be truncated.
Root cause
Other
Action
Firm issued a letter notifying users of systems that when transferring image data to a DICOM server for any patient born on January 1, to verify that the Patient ID is correct on the DICOM server after the transfer. Firm will modify the software by January 2005.
Quantity
39 units
Distribution
Nationwide.
Lot, serial or model codes
No specific codes were listed.
510(k) numbers
not on file
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

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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

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