The Recall Desk
ModerateFDA (Devices)·Z-1101-2013·Announced 2013-04-17

Toshiba MRI Systems Recalled for LCD Monitor Backlight Failure

Toshiba American Medical Systems is recalling 27 Titan X and Titan 3T MRI systems because the console LCD monitor backlight may turn off during use.

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 source explicitly states that the risk of a serious health hazard is very low and that other system parts continue to operate normally, aligning with the rubric for low-risk or precautionary recalls.

Plain-English summary

Toshiba American Medical Systems Inc is recalling 27 units of the MRT-1504/A4 Titan X MRI System and the MRT-30 I0A/5 Titan 3T MRI System. The recall involves specific product numbers MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, and MZKT-UPKHE/S1. These systems were distributed nationwide in the United States, including in Illinois, New Hampshire, Massachusetts, Michigan, Missouri, Puerto Rico, Nevada, New Mexico, Minnesota, Idaho, New York, Ohio, North Carolina, Arizona, Mississippi, Louisiana, Oregon, Pennsylvania, California, and Connecticut.

The recall was initiated because the LCD monitor used in the system console may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the MRI system is operating. The source text notes that other parts of the system continue to operate normally, and the risk of a serious health hazard is described as very low.

The source text does not provide specific instructions for consumers or healthcare facilities on how to proceed with the recall or contact information for the recalling firm.

The recalled product

Product
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — MRI System
Hazard
Affected units
27

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)

  • Product Numbers: MRT-1504/A4
  • MRT-1504/S4
  • MRT-3010/A5
  • MZKT-UPKHE/S1. Serial Numbers unique to each consignee.

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

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