The Recall Desk
HighFDA (Devices)·Z-0201-2014·Announced 2013-11-20

Toshiba Titan 3T MRI System Recalled for SAR Display Error

Toshiba is recalling 18 Titan 3T MRI systems because they may display lower Specific Absorption Rate (SAR) values than actual when used with specific coils.

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, and the hazard involves a risk-of-harm product (MRI system) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Toshiba America Medical Systems, Inc. is recalling 18 units of the Titan 3T MRI System (MRT-3010A/5) due to a potential problem with Specific Absorption Rate (SAR) values. The recall affects systems distributed nationwide in California, Florida, Georgia, Iowa, Nevada, New York, Louisiana, Indiana, Pennsylvania, Oregon, Texas, and Wisconsin.

The issue occurs when the MRI system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A). In these configurations, the operating monitor may display SAR values that are lower than the actual SAR values. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities should identify affected units by checking the serial numbers listed in the recall notice. Affected serial numbers include A5B1192003, A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, and A5B1182002.

The recalled product

Product
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Manufacturer
Toshiba American Medical Systems Inc
Category
Medical Device — MRI System
Hazard
Affected units
18

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 (20)

  • Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004
  • A5B11Y2005
  • A5B11Z2007
  • A5C1212008
  • A5C1212009
  • A5C1222010
  • A5C1232011
  • A5C1252012
  • A5C1262013
  • A5C1282014
  • A5C1292015
  • A5C12X2016
  • A5C12Y2017
  • A5C12Z2018
  • A5D1312019
  • A5D1322020
  • A5D1362021
  • XIB-A5A1082001
  • XIB-A5B11Y2006
  • A5D1372022

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Related recalls

Same manufacturer · Toshiba American Medical Systems Inc

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