Nidek AFC-330 Fundus Camera Recalled for Image Defects
Nidek Inc. is recalling 185 AFC-330 Non-Mydriatic Auto Fundus Cameras because images may contain white spots that could affect diagnosis.
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. The hazard involves potential diagnostic errors due to image defects, but no injuries or illnesses are reported in the source text.
Plain-English summary
Nidek Inc. is recalling 185 units of the Non-Mydriatic Auto Fundus Camera, Model AFC-330. This ophthalmic camera is used to capture images of the retina and anterior segment of the eye. The devices were distributed nationwide by Nidek, Inc. and Marco Opthalmic Inc., and manufactured by Nidek Co. Ltd. in Japan.
The recall was initiated because images taken by the AFC-330 may contain a white spot. This defect may affect the diagnosis or evaluation of the captured images. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and consumers should stop using the affected cameras and contact Nidek Inc. for further instructions. Specific serial numbers for the 185 affected units are listed in the official recall documentation.
The recalled product
- Product
- Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
- Manufacturer
- Nidek Inc
- Affected units
- 185
Distribution
Distributed nationwide across the United States.
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