CompView NuCARTGN Medical Display Recall Due to Spring Arm Detachment Risk
CompView Medical is recalling 10 NuCARTGN mobile display units because the spring arm may detach if the securing ring was not installed correctly.
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 (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical hazards without confirmed adverse events.
Plain-English summary
CompView Medical, LLC is recalling 10 units of the Model NuCARTGN mobile display and image management platform. The NuCART is used in Minimally Invasive Surgery (MIS) environments to route and display video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in surgery suites, ambulatory surgery centers, and other medical settings.
The recall is being issued because the attachment of the NuCART Spring Arm to the horizontal boom may come apart if the securing ring (snap ring) was not installed correctly. This defect could cause the spring arm to release and detach.
The affected units were distributed nationwide in the United States, including Arizona, California, Colorado, Georgia, Ohio, and Tennessee. Specific lot numbers and serial codes are listed in the official recall documentation. Healthcare facilities and users should stop using the affected units and contact CompView Medical for further instructions.
The recalled product
- Product
- Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC…
- Manufacturer
- CompView Medical, LLC
- Affected units
- 10
Distribution
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