Z-2312-2016Class II

3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The...

Name: Z-2312-2016 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The...
Creator: NeoCoil, LLC
Published: 2016-06-17
License: https://open.fda.gov/license/

NeoCoil, LLC / initiated 2016-06-17 / Terminated / root cause: manufacturing process

FDA source

NeoCoil, LLC began a recall of 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... on 2016-06-17. FDA classified it as Class II and gives the reason as "There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2312-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-17
Posted: 2016-08-01
Terminated: 2017-11-21
Recalling firm: NeoCoil, LLC
Product: 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.
Product code: MOS Coil, Magnetic Resonance, Specialty
Reason for recall: There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: NeoCoil sent an "Urgent Medical Device Recall" letter dated 17 June 2016. The letter described the problem and the product involved in the recall. Advised consignee to quarantine the product and if the product was further distributed to identify the customers and provide the list to NeoCoil. The recall will be carried to the user level. Requested consignee to complete and return the response form. For questions call 262-522-6127.
Quantity in commerce: 39 (11 US, 28 OUS)
Distribution: Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
Product codes and lots: "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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2312-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2312-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-01

Product code MOS

K141832Class II3T 16Ch Flex Speeder, Medium , 3T 16Ch Flex Speeder, LargeNeocoil, LLC / cleared 2014-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)