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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Toshiba American Med Sys Inc
Lot Codes / Batch Numbers
All serial numbers.
Products Sold
All serial numbers.
Toshiba American Med Sys Inc is recalling Magnetic Resonance Imaging System Core Software, Software installed in all of the following: due to Software anomaly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly.
Recommended Action
Per FDA guidance
Firm will send letters followed by visits to install software repair.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026