U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Coil, magnetic resonance, specialty - Product Code MOS
원인
Potential for higher than specified surface temperatures. use of 3.0t gem flex system may result in patient warming or burns.
조치
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.
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