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 Ar
Check against the official notice below — it lists the full affected range.
NeoCoil, LLC is recalling the 3.0T GEM Flex coil system, which is used in medical imaging and includes three sizes of coil arrays and one interface box. The recall affects 2,121 units that were distributed nationwide across the United States. The recalled systems are identified by specific lot and serial numbers listed in the recall documentation.
The reason for the recall is that the 3.0T GEM Flex system has the potential to reach higher temperatures than specified, which may result in patient warming or burns during use. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
Reason for recall: Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns. Distribution: US Nationwide Distribution Quantity: 2121 Lot/code info: 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 757827MR2 0000033-4-0081 757827MR2 0000SGH225PYJJ 757827MR2 0000034-4-0007 305461MR1 0000040-4-0070 305461MR1 0000033-4-0070 305461MR1 0000034-4-0110 847872ZMR2 0000040-4-0114 847872ZMR2 0000033-4-0114 847872ZMR2 0000034-4-0095 330344MR750W 0000040-4-0098 330344MR750W 0000033-4-0099 330344MR750W 0000034-4-0094 616774MR750W 0000040-4-0097 616774MR750W 0000033-4-0098 616774MR750W 0000040-4-0276 386FNSBMR3T 0000033-4-0279 386FNSBMR3T 0000034-4-0260 386FNSBMR3T 0000034-4-0140 217876DMH3T 0000040-4-0145 217876DMH3T 0000033-4-0146 217876DMH3
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.