Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 10, 2016
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
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
NeoCoil, LLC recalled 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems M… - a moderate-severity action.
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems M… was recalled by NeoCoil, LLC in August 10, 2016. Reason: There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large …. Check the official notice for the remedy. Verify recall #Z-2312-2016 with the FDA Devices before acting.
The recall
NeoCoil, LLC issued this moderate-severity FDA Devices recall-There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large ….
- Moderate
- severity level
- Class II
- classification
- August 10, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2312-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2312-2016) was formally reported on August 10, 2016, with the manufacturer initiating the action on June 17, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. NeoCoil, LLC is listed as the recalling firm, operating out of Pewaukee, WI. Federal records list the affected scope as 39 (11 US, 28 OUS).
The documented reason for this recall is: There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. Distribution data in the federal record shows the product reached: Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
39 (11 US, 28 OUS)
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2312-2016 |
| Date reported | August 10, 2016 |
| Date initiated | June 17, 2016 |
| Recalling firm | NeoCoil, LLC |
| Firm location | Pewaukee, WI |
| Affected scope | 39 (11 US, 28 OUS) |
| Distribution | Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2312-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by NeoCoil, LLC. Units affected: 39 (11 US, 28 OUS).
Why was this product recalled? ▼
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2312-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2312-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 10, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.