{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Pewaukee", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "72976", "recalling_firm": "NeoCoil, LLC", "address_1": "N27W23910 Paul Rd Ste A", "address_2": "N/A", "postal_code": "53072-6204", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-1027-2016", "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", "product_quantity": "2121", "reason_for_recall": "Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.", "recall_initiation_date": "20151218", "center_classification_date": "20160229", "termination_date": "20161012", "report_date": "20160309", "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 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