Class II — NeoCoil, LLC
| Recalling firm | NeoCoil, LLC |
|---|---|
| Registered facility | NEOCOIL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. |
| 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. |
| Quantity | 39 (11 US, 28 OUS) |
| Distribution | Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom. |
| Initiated | 2016-06-17 |
| Classified | 2016-08-01 |
| Terminated | 2017-11-21 |
| Recall number | Z-2312-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — NeoCoil, LLC (Z-2312-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74477/
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