RegWardenFDA facility compliance records
Company

NeoCoil, LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2016: 1 recalls12015120162017201820192020202120222023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2016-06-17
    There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
  • Class IITerminated2015-12-18
    Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NeoCoil, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9099325-neocoil-llc/

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