MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5
FDA device recall Z-2135-2016 · posted 2016-07-06 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LNH
- Quantity affected
- 33 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-04-14
- Date posted
- 2016-07-06
- Date terminated
- 2017-03-30
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vantage Titan 3T (K152371) | Toshibamedical Systems Corporation | 2015-10-23 |