Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1027-2016 — 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

U.S. FDA — Device Enforcement · United States · 2015-12-18 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1027-2016
Date of alert: 2015-12-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: NeoCoil, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00000040

Reported risk: Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related