Karl Storz Recalls Essential NEO Audio/Visual Units Due to Overheating Cable
Karl Storz Endoscopy is recalling 968 Essential NEO audio/visual integration units because the connected power cable could overheat, generate smoke, and cause the peripheral to stop working.
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 smoke generation and overheating) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Karl Storz Endoscopy-America is recalling the Essential NEO Audio/Visual Integration Unit. The recall involves 968 units that were distributed nationwide to specific states and internationally to Canada.
The recall is being issued because the connected power cable could potentially become overheated. This overheating could result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.
The source text does not specify instructions for consumers or healthcare facilities on how to handle the recalled units, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- Essential NEO, Audio/Visual Integration Unit An audio/visual integration unit.
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- Affected units
- 968
Distribution
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