NeoCoil 3T 16ch Flex SPEEDER Large Coil Recalled for Surface Temperature Risk
NeoCoil, LLC is recalling 39 units of the 3T 16ch Flex SPEEDER Large Coil due to a potential for higher than specified surface temperatures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential burn injury from high surface temperatures) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
NeoCoil, LLC is recalling 39 units of the 3T 16ch Flex SPEEDER Large Coil (NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A). The recall involves 11 units in the United States and 28 units outside the United States.
The recall is being conducted because there is a potential for higher than specified surface temperatures involving the device. The coils are used in conjunction with Toshiba 3T Magnetic Resonance Scanners to produce diagnostic images of various body parts.
The affected units were distributed worldwide to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, the United Kingdom, and the United States. Users should contact NeoCoil, LLC for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- NeoCoil, LLC
- Category
- Medical Device — MRI Coil
- Hazard
Distribution
Distributed in 1 state:
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