Recall Z-1027-2016 ยท MOS Coil, Magnetic Resonance, Specialty
NeoCoil, LLC
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 numb
| Date | Dec 18, 2015 |
| Status | Terminated |
| Reason | Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. |
| Root cause | Component change control |
| 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. |
| Quantity | 2121 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103342 | 3.0T METAFLEXCOIL Neocoil, LLC, Dec 23, 2010 |