Recall Z-2135-2016— Toshiba American Medical Systems Inc

Name: FDA recall Z-2135-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-14

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2016-04-14, terminated 2017-03-30. It names one FDA 510(k) clearance: K152371. Product: 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.. Reason: A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Terminated: 2017-03-30
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K152371 — Vantage Titan 3TToshibamedical Systems Corporation·cleared 2015-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.

Data sourced from openFDA. This site is unofficial and independent of the FDA.