CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report
Titan 3T MRI System, MRT-3010A/5 recalled by Toshiba American Medical
Toshiba American Medical Systems is recalling Titan 3T MRI System, MRT-3010A/5, distributed nationwide in the US. The recall was initiated on 28 Oct 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0201-2014
- FDA event ID
- 66725
- Recalling firm
- Toshiba American Medical Systems, Tustin, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Oct 2013
- FDA classified
- 12 Nov 2013
- Reported
- 20 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 28 Oct 2013 | Recall initiated by company | |
| 12 Nov 2013 | Classified by FDA | +15 days |
| 20 Nov 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
Product as listed by the FDA
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Where it was distributed
USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Nationwide CaliforniaFloridaGeorgiaIowaIndianaLouisianaNevadaNew YorkOregonPennsylvaniaTexasWisconsin
Questions about this recall
Why was it recalled?
Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (SAR) values when using the Toshiba Titan 3T System. When the system is used in combination with either the QD Head Coil (MJQH-142A) or the Large Knee SPEEDER (MJAJ-182A), SAR values lower than the actual SAR values may be displayed on the operating monitor.
Which lots are affected?
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, A5B1182002.
Where was it sold?
USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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