The Recall Desk
HighFDA (Devices)·Z-2135-2016·Announced 2016-07-13

Toshiba Vantage Titan 3T MRI System Recalled for Gradient Coil Issue

Toshiba American Medical Systems is recalling 33 Vantage Titan 3T MRI systems due to a potential problem with the gradient coil.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The source text describes a 'potential problem' with the gradient coil but does not report any injuries, illnesses, or deaths. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Toshiba American Medical Systems Inc is recalling 33 units of the MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System. The recall is due to a potential problem associated with the gradient coil (ASGC) in the Titan 3T MRI System.

The affected units were distributed nationwide in the United States. The recall covers specific serial codes listed in the agency documentation, including A5A1082001 through A5P1562034.

Healthcare facilities should contact Toshiba American Medical Systems for instructions on how to address the potential gradient coil issue.

The recalled product

Product
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the featur
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — MRI System
Hazard
Affected units
33

Distribution

Distributed nationwide across the United States.

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