Reported Nov 20, 2013 · Terminated
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Toshiba American Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Toshiba American Medical Systems Inc · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
Titan 3T MRI SystemMRT-3010A/5
- Product UsageUsage: MRI system
- Lot codes and dates
- Lot numbers not utilized
- Serial Numbers
A5B1192003 A5B1192004A5B11Y2005A5B11Z2007A5C1212008A5C1212009A5C1222010A5C1232011A5C1252012A5C1262013A5C1282014A5C1292015A5C12X2016A5C12Y2017A5C12Z2018A5D1312019A5D1322020A5D1362021XIB-A5A1082001XIB-A5B11Y2006A5D1372022A5B1182002
- Amount recalled
- 18 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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