3T 16ch Flex SPEEDER Coil — Class II medical device recall Z-2312-2016
Terminated recall by NeoCoil, LLC, reported 2016-08-10, distributed in GA. There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large C
| Recall number | Z-2312-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeoCoil, LLC, Pewaukee, WI, United States |
| Recall initiated | 2016-06-17 |
| Classified | 2016-08-01 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-11-21 |
| Distributed | GA |
| Countries outside the US | DE, ES, GB, JP, KR, NL, PK |
| Serial numbers | 046-4-0012, 046-4-0013, 046-4-0014, 046-4-0015, 046-4-0016, 046-4-0017, 046-4-0018, 046-4-0019, 046-4-0020, 046-4-0021, 046-4-0022, 046-4-0023, 046-4-0024, 046-4-0025, 046-4-0026, 046-4-0027, 046-4-0028, 046-4-0029, 046-4-0030, 046-4-0031, 046-4-0032, 046-4-0033, 046-4-0034, 046-4-0035, 046-4-0036 and 14 more |
| Model numbers | MJAJ-222A, NC046200 |
Product
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
Reason for recall
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
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-2312-2016. 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.