Neusoft NeuViz 64 CT Scanner Recalled for Teflon Compensator Failure
Neusoft Medical System Co is recalling NeuViz 64 CT scanners because the Teflon A-plane compensator degrades under X-ray exposure, causing premature failure and image artifacts.
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 is classified as FDA Class II. The hazard involves a risk of harm (image artifacts) from a medical device defect, but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a High severity score.
Plain-English summary
Neusoft Medical System Co is recalling the NeuViz 64 Multi-slice CT Scanner System. The recall involves 5 units installed in the United States, distributed to Illinois, Massachusetts, Texas, South Carolina, and Puerto Rico, as well as units in various international locations.
The recall is due to a defect in the A-plane compensator, which is made of Teflon. This material becomes fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation, leading to premature failure. This failure is indicated by the presence of pin or ring artifacts in the medical images produced by the scanner.
Healthcare facilities with these units should contact Neusoft Medical System Co for further instructions on how to address the defect. The source text does not specify specific actions for patients or detailed remediation steps beyond the identification of the failure mode.
The recalled product
- Product
- Neusoft NeuViz 64 Multi-slice CT Scanner System
- Manufacturer
- Neusoft Medical System Co
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NeuViz 16/64 Series
Distribution
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