KaVo Orthopantomograph OP 3D Cone-Beam CT System Firmware Recall
KaVo Dental Technologies is recalling 230 Orthopantomograph OP 3D cone-beam CT systems due to a defect in firmware versions 2.1.0 and 2.1.1.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible health consequences. Since no specific injuries, illnesses, or critical safety hazards are reported in the source text, it falls under the Moderate category for a precautionary firmware defect.
Plain-English summary
KaVo Dental Technologies LLC is recalling 230 units of the Orthopantomograph OP 3D cone-beam CT system. The recall is due to a defect in the device firmware, specifically affecting versions 2.1.0 and 2.1.1.
The affected devices were distributed in North Carolina. The source text does not specify the exact nature of the firmware defect or any reported injuries or illnesses associated with the use of these devices.
Consumers and healthcare providers who possess these specific firmware versions should contact KaVo Dental Technologies LLC for further instructions on how to address the defect.
The recalled product
- Product
- cone-beam CT system
- Manufacturer
- KaVo Dental Technologies LLC
- Category
- Medical Device — Dental Imaging
- Hazard
- Affected units
- 230
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)
- versions 2.1.0 and 2.1.1
Distribution
Distributed in 1 state:
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