MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interface designed for ease of use.
This recall has been terminated (originally issued July 6, 2016).
- Recall Initiated
- April 14, 2016
- Posted
- July 6, 2016
- Terminated
- March 30, 2017
- Recall Number
- Z-2135-2016
- Quantity
- 33 units
- Firm Location
- Tustin, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Distribution
US Nationwide Distribution
Lot / Code Info
A5A1082001 A5B1182002 A5B1192003 A5B1192004 A5B11Y2005 A5B11Y2006 A5B11Z2007 A5C1212008 A5C1212009 A5C1222010 A5C1232011 A5C1252012 A5C1262013 A5C1282014 A5C1292015 A5C12X2016 A5C12Y2017 A5C12Z2018 A5D1312019 A5D1322020 A5D1362021 A5D1392023 A5D13X2024 A5D13Y2025 A5D13Y2026 A5D13Z2027 A5C1412028 A5C1422029 A5D1492030 A5D14X2031 A5D14X2032 A5E1522033 A5F1592035 A5D1372022 A5P1562034
Root Cause
Device Design
Action Taken
An Urgent Medical Device Notification letter was sent to customers to alert them to a potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System. The letter informs the customers of the problem identify and the corrective action. Customers are informed that their Toshiba service representative will contact them for an appointment to install the modified software on their system when it becomes available. Customers are instructed to complete the attached customer response form and fax it to the toll-free number shown at the top of the form; sent via email to TAMS-RegulatoryAffairs@toshiba.com. Customers with any questions are instructed to contact Paul Biggins at (800) 421-1968 or to contact their local Toshiba representative at (800) 521-1968.