CLASS II Device recall · Reported 12 Sep 2012 · FDA Enforcement Report
Toshiba Ultra-Short Magnetic Resonance Imaging System recalled
Toshiba American Medical Systems is recalling Toshiba Ultra-Short Magnetic Resonance Imaging System, Excelart Vantage, distributed nationwide in the US. The recall was initiated on 21 Feb 2012 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-2315-2012
- FDA event ID
- 62928
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2012
- FDA classified
- 6 Sep 2012
- Reported
- 12 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 21 Feb 2012 | Recall initiated by company | |
| 6 Sep 2012 | Classified by FDA | +198 days |
| 12 Sep 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
Product as listed by the FDA
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Where it was distributed
US (nationwide) distribution including the states of Ohio and Texas.
Questions about this recall
Why was it recalled?
The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
Which lots are affected?
MRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143.
Where was it sold?
US (nationwide) distribution including the states of Ohio and Texas.
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.
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