CLASS II Device recall · Reported 5 Sep 2012 · FDA Enforcement Report
Excelart Vantage, Atlas, and Titan MRI Systems, Mrt recalled
Toshiba American Medical Systems is recalling Excelart Vantage, Atlas, and Titan MRI Systems, Mrt-1503 and Mrt-1504, distributed nationwide in the US. The recall was initiated on 13 May 2008 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2278-2012
- FDA event ID
- 62853
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2008
- FDA classified
- 27 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 13 May 2008 | Recall initiated by company | |
| 27 Aug 2012 | Classified by FDA | +1567 days |
| 5 Sep 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The status display in the sequence queue window may not change from "Current" to "Done".
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
The status display in the sequence queue window may not change from "Current" to "Done".
Which lots are affected?
Models MRT-1503 and MRT-1504 " MRT-1503 systems with software V9.01 *R240 through V9.20*R242 " MRT-1504 systems with software V9.21 *R24
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Toshiba American Medical Systems
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Diagnostic Ultrasound System, Aplio I-series recalled | Toshiba American Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Infx-8000V Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000H Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000F Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
| Device | CLASS II | Infx-8000C Fluoroscopic X-Ray Systems recalled | Toshiba American Medical Systems | Other | CA |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |