Moderate FDA (Devices)·Z-2315-2012·Announced 2012-09-12

Toshiba MRI System Recalled for Potential Power Cable Terminal Issue

Toshiba American Medical Systems Inc. is recalling three MRI systems due to a potential problem with the position of the hold in the lug terminals on power cables.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the defect is described as a 'potential problem' without explicit evidence of significant harm.

Plain-English summary

Toshiba American Medical Systems Inc. is recalling three units of the Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage (MRT-1503/P5-Vantage MRI System). The recall was initiated due to a potential problem with the position of the hold in the lug terminals on the power cables connected to the terminal blocks on the gradient coil.

The affected units were distributed nationwide in the United States, including the states of Ohio and Texas. The specific serial codes for the recalled units are P5A0632002, P5B06Y2005, P5B0712006, and P3F11Z2143.

The source text does not specify the actions consumers or facility operators should take, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product: Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Manufacturer: Toshiba American Medical Systems Inc
Category: Medical Device — MRI System
Hazard: electrical-defect
Affected units: 3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Toshiba American Medical Systems Inc

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Same hazard · electrical defect