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Recall Observatory FDA recall evidence

Device product

Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.

Z-2315-2012

February 21, 2012

Class II

Product summary

Firm
Toshiba American Medical Systems Inc
Event
Event 62928
Status
Terminated
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-2315-2012

Official wording

Reason: 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.

Code information: MRT-1503/P5-Vantage MRI System. Serial Codes: P5A0632002, P5B06Y2005, P5B0712006, P3F11Z2143.

Distribution pattern: US (nationwide) distribution including the states of Ohio and Texas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.