Recall Z-2312-2016
NeoCoil, LLC · initiated June 17, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
Reason for recall
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-2312-2016
- Initiated
- June 17, 2016
- Terminated
- November 21, 2017
- Product code
- MOS – Coil, Magnetic Resonance, Specialty
- Quantity
- 39 (11 US, 28 OUS)
- Distribution
- Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.
- Recalling firm
- NeoCoil, LLC, Pewaukee, WI