Recall Z-2312-2016 ยท MOS Coil, Magnetic Resonance, Specialty
NeoCoil, LLC
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 diagnost
| Date | Jun 17, 2016 |
| Status | Terminated |
| Reason | There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. |
| 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 | 39 (11 US, 28 OUS) |
| Distribution | Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE Neocoil, LLC, Jul 31, 2014 |