CLASS II Device recall · Reported 10 Aug 2016 · FDA Enforcement Report
3T 16ch Flex Speeder Coil, Large, NeoCoil recalled
NeoCoil is recalling 3T 16ch Flex Speeder Coil, Large, NeoCoil, distributed nationwide in the US. The recall was initiated on 17 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2312-2016
- FDA event ID
- 74477
- Recalling firm
- NeoCoil, Pewaukee, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2016
- FDA classified
- 1 Aug 2016
- Reported
- 10 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Spinal Implants
Timeline
| 17 Jun 2016 | Recall initiated by company | |
| 1 Aug 2016 | Classified by FDA | +45 days |
| 10 Aug 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
Where it was distributed
Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
Questions about this recall
Is 3T 16ch Flex Speeder Coil, Large, NeoCoil recalled?
Yes. NeoCoil recalled 3T 16ch Flex Speeder Coil, Large, NeoCoil on 17 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2312-2016.
Why was it recalled?
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Which lots are affected?
"Neocoil serial Number" 046-4-0012 046-4-0013 046-4-0014 046-4-0015 046-4-0016 046-4-0017 046-4-0018 046-4-0019 046-4-0020 046-4-0021 046-4-0022 046-4-0023 046-4-0024 046-4-0025 046-4-0026 046-4-0027 046-4-0028 046-4-0029 046-4-0030 046-4-0031 046-4-0032 046-4-0033 046-4-0034 046-4-0035 046-4-0036 046-4-0037 046-4-0038 046-4-0039 046-4-0040 046-4-0041 046-4-0042 046-4-0043 046-4-0044 046-4-0045 046-4-0046 046-4-0047 046-4-0048 046-4-0049 046-4-0050
Where was it sold?
Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from NeoCoil
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 0T GEM Flex Coil recalled by NeoCoil | NeoCoil | Temperature Abuse | Nationwide |
Other Spinal Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |