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Terminated

Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.

FDA Recall Z-0201-2014 · Posted 2013-11-13

Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2013-10-28
Date Terminated2014-12-24
Product Quantity18 units

Reason for Recall

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102489VANTAGE TITAN 3TToshiba Medical Systems Corporation, Japan · 2011-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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