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Terminated

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

FDA Recall Z-1027-2016 · Posted None

Recalling FirmNeoCoil, LLC
Recall StatusTerminated
Product CodeMOS
Date Initiated2015-12-18
Date Terminated2016-10-12
Product Quantity2121

Reason for Recall

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

Firm Action

Distributor was sent a NeoColi "Urgent Medical Device Recall" letter dated 18 December 2015. The letter described the problem and the product involved in the recall. Consignee was advised to quarantine the product and to identify their customers and provide a list to NeoCoil. NeoCoil will contact each customer for correction and removal of the devices. Requested consignee to complete and return the response form. For questions call Michael Leigh at 261-522-6127.

Root Cause

Component change control

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1033423.0T METAFLEXCOILNeocoil, LLC · 2010-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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