FDA Device recall Z-1027-2016

NeoCoil 3.0T GEM Flex Coil

FDA Device
Class II
terminated
Published 2016-03-09

On 2016-03-09 the FDA classified a Class II recall of NeoCoil 3.0T GEM Flex Coil by Neocoil, citing potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1027-2016
Classification	Class II
Status	terminated
Initiated	2015-12-18
Published	2016-03-09
Last updated	2026-09-13 11:54 UTC
Company	Neocoil
Distribution	US

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.

Identifiers

code_info	Mfg Lot or Serial # System ID 0000034-4-0130 608263MR5W 0000040-4-0135 608263MR5W 000032E-4-0151 608263MR5W 033-4-0… Mfg Lot or Serial # System ID 0000034-4-0130 608263MR5W 0000040-4-0135 608263MR5W 000032E-4-0151 608263MR5W 033-4-0151 608263MR5W 0000040-4-0202 602863MR 0000033-4-0204 602863MR 034-4-0265 602863MR 040-4-0076 602863MR 0000034-4-0250 703478MR2DV 0000040-4-0270 703478MR2DV 033-4-022 703478MR2DV 0000033-4-0272 703478MR2DV 034-4-0255 506648MR4 040-4-0275 506648MR4 040-4-0020 506648MR4 033-4-0277 506648MR4 034-4-0071 608265MR750W 0000040-4-0381 608265MR750W 0000033-4-0384 608265MR750W 034-4-0345 608265MR750W 0000034-4-0093 708346MR3 0000040-4-0096 708346MR3 0000033-4-0088 708346MR3 034-4-0352 269DVMR 040-4-0392 269DVMR 033-4-0395 269DVMR 0000034-4-0144 808873MR750W 0000033-4-0151 808873MR750W 0000040-4-0150 808873MR750W 0000034-4-0112 270798MR2 0000040-4-0118 270798MR2 0000033-4-0118 270798MR2 034-4-0089 650723NCMR1 033-4-0258 650723NCMR1 033-4-0134 650723NCMR1 0000034-4-0086 281274MR2 0000040-4-0089 281274MR2 0000033-4-0090 281274MR2 0000034-4-0076 75

code_info

Mfg Lot or Serial # System ID 0000034-4-0130 608263MR5W 0000040-4-0135 608263MR5W 000032E-4-0151 608263MR5W 033-4-0…

Mfg Lot or Serial # System ID 0000034-4-0130 608263MR5W 0000040-4-0135 608263MR5W 000032E-4-0151 608263MR5W 033-4-0151 608263MR5W 0000040-4-0202 602863MR 0000033-4-0204 602863MR 034-4-0265 602863MR 040-4-0076 602863MR 0000034-4-0250 703478MR2DV 0000040-4-0270 703478MR2DV 033-4-022 703478MR2DV 0000033-4-0272 703478MR2DV 034-4-0255 506648MR4 040-4-0275 506648MR4 040-4-0020 506648MR4 033-4-0277 506648MR4 034-4-0071 608265MR750W 0000040-4-0381 608265MR750W 0000033-4-0384 608265MR750W 034-4-0345 608265MR750W 0000034-4-0093 708346MR3 0000040-4-0096 708346MR3 0000033-4-0088 708346MR3 034-4-0352 269DVMR 040-4-0392 269DVMR 033-4-0395 269DVMR 0000034-4-0144 808873MR750W 0000033-4-0151 808873MR750W 0000040-4-0150 808873MR750W 0000034-4-0112 270798MR2 0000040-4-0118 270798MR2 0000033-4-0118 270798MR2 034-4-0089 650723NCMR1 033-4-0258 650723NCMR1 033-4-0134 650723NCMR1 0000034-4-0086 281274MR2 0000040-4-0089 281274MR2 0000033-4-0090 281274MR2 0000034-4-0076 75

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1027-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.