Titan 3T MRI System — Class II medical device recall Z-0201-2014
Terminated recall by Toshiba American Medical Systems Inc, reported 2013-11-20, distributed nationwide. Toshiba America Medical Systems, Inc. is recalling due to a potential problem with Specific Absorption Rate (S
| Recall number | Z-0201-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2013-10-28 |
| Classified | 2013-11-12 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-12-24 |
| Distributed | Nationwide (US) |
| Quantity | 18 units |
| Serial numbers | A5B1182002, A5B1192003, A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, A5D1372022, XIB-A5A1082001, XIB-A5B11Y2006 |
Product
Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0201-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.