Titan 3T MRI System recall
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
Why was Titan 3T MRI System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 18 units
- Distribution
- USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.
- Recall date
- November 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)