Recall Z-0201-2014 ยท LNH System, Nuclear Magnetic Resonance Imaging
Toshiba American Medical Systems Inc
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
| Date | Nov 13, 2013 (initiated Oct 28, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Toshiba America Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION". letter dated October 28, 2013 via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS for retention. The letter listed Device, Serial Number, reason for recall, problem, corrective actions, request to customers, and contact information. |
| Quantity | 18 units |
| Distribution | USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102489 | VANTAGE TITAN 3T Toshiba Medical Systems Corporation, Japan, Aug 2, 2011 |