Toshiba American Medical Systems Inc: Medical Device Recall in 2013 - (Recall #: Z-0201-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 28, 2013

Date Posted: November 20, 2013

Recall Number: Z-0201-2014

Event ID: 66725

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.

Status: Terminated

Product Quantity: 18 units

Code Information:

Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated