NeoCoil 3 — Class II medical device recall Z-1027-2016
Terminated recall by NeoCoil, LLC, reported 2016-03-09, distributed nationwide. Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient wa
| Recall number | Z-1027-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NeoCoil, LLC, Pewaukee, WI, United States |
| Recall initiated | 2015-12-18 |
| Classified | 2016-02-29 |
| Reported by FDA | 2016-03-09 |
| Terminated | 2016-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,121 |
| UPC / GTIN / UDI-DI | 00082427040135, 00082427120110 |
| Model numbers | 3.0TGEM, 5430008-2, 5430008-3, 5430008-4, 5430008-5 |
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
Reason for recall
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
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-1027-2016. 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.