Device product
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Z-0201-2014
Product summary
- Event
- Event 66725
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-0201-2014
Official wording
Reason: 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.
Code information: 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.
Distribution pattern: USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
Derived failure modes
-
Unknown
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.