Class II — NeoCoil, LLC
| Recalling firm | NeoCoil, LLC |
|---|---|
| Registered facility | NEOCOIL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. |
| Product | NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner |
| Quantity | 2121 |
| Distribution | US Nationwide Distribution |
| Initiated | 2015-12-18 |
| Classified | 2016-02-29 |
| Terminated | 2016-10-12 |
| Recall number | Z-1027-2016 |
| 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-1027-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72976/
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