Recall Z-1027-2016— NeoCoil, LLC

Name: FDA recall Z-1027-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Class II · Terminated

Class II FDA medical device recall by NeoCoil, LLC, initiated 2015-12-18, terminated 2016-10-12. It names one FDA 510(k) clearance: K103342. Product: 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. Reason: Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns..

Recalling firm: NeoCoil, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Terminated: 2016-10-12
Firm location: Pewaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K103342 — 3.0T METAFLEXCOILNeocoil, LLC·cleared 2010-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.