MRT-1504/A4 - Titan X MRI System recallZ-1101-2013 · Toshiba American Medical Systems Inc · initiated Oct 15, 2012
Class II Terminated All recalls posted in April 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Toshiba American Medical Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
It was found that there is a problem with the LCD monitor used in the console. The LCD monitor may become blank during use. Specifically, the backlight of the LCD monitor may turn off while the system is in use, causing the LCD monitor to become blank. However, the other parts of the system continue to operate normally, and the risk of a serious health hazard is therefore very low. The LCD Moni
FDA root cause category: Nonconforming Material/Component
What the company is doing
Toshiba sent an Urgent Medical Device Correction letter dated October 1, 2012 via USPS return receipt mail to all affected customers . The letter identified the affected product, problem and actions to be taken. The letter contains a return reply form that is to be faxed to TAMS for retention. For questions contact your local Toshiba representative at 800-521-1968.
Recall details
- Recall number
- Z-1101-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 15, 2012
- Posted by the FDA
- Apr 11, 2013
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 27 units
- Product code
- LNH
- FDA submissions
- K113093, K120638
- Distribution
- USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.
Product description
MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
Code information (models, lots, serial numbers)
Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.
Other devices under the same FDA submission
2 devices cleared under K113093, K120638 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vantage Titan 3T MRT-3010Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
- TOSHIBA SUPERCONDUCTING MRI SYSTEM Vantage Titan MRT-1504Canon Inc. · System, nuclear magnetic resonance imaging2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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