NeoCoil 3.0T GEM Flex Coil
Medical device recall Z-1027-2016. Published in FDA’s Enforcement Report on Mar 9, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 9, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2121 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
2121, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,988 characters
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 217876DMH3T 0000034-4-0216 410328MR3T 0000040-0-0224 410328MR3T 0000033-4-0227 410328MR3T 034-4-0313 716740MR1 040-4-0329 716740MR1 033-4-0329 716740MR1 0000034-4-0177 415CBMRP 0000040-4-0182 415CBMRP 0000033-4-0183 415CBMRP 0000034-4-0043 808485MR2 0000040-4-0047 808485MR2 033-4-0323 808485MR2 034-4-0267 415UCBHMR1 040-4-0284 415UCBHMR1 033-4-0285 415UCBHMR1 033-4-0352 843815750W 040-4-0055 843815750W 0000034-4-0221 843815750W 034-4-0272 415UCBHMR2 040-4-0288 415UCBHMR2 033-4-0290 415UCBHMR2…
FDA’s list runs to 28,992 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 18, 2015.
- FDA classified it on Feb 29, 2016.
- FDA’s Enforcement Report published it on Mar 9, 2016.
- FDA terminated it on Oct 12, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NeoCoil, LLC, of Pewaukee, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 28,992 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.