Clarity Medical Systems Recalls RetCam Devices Due to Age Calculation Error
Clarity Medical Systems is recalling RetCam 3, Portable, and Shuttle devices because a software error causes incorrect patient age calculations.
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 situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a software calculation error regarding patient age, which is a data integrity issue rather than a direct physical hazard like electrical shock or radiation exposure, fitting the Moderate category for non-critical software defects.
Plain-English summary
Clarity Medical Systems, Inc. is recalling the RetCam 3, RetCam Portable, and RetCam Shuttle ophthalmic imaging devices. The recall involves 166 RetCam Shuttles, 288 RetCam 3 units, and 23 RetCam Portables. These devices are used for general ophthalmic imaging, including retinal, corneal, and external imaging.
The recall is due to a software anomaly in versions 6.0.x, 6.1.x, and 6.2x where the patient's age is calculated incorrectly. The affected devices were distributed worldwide, including in the United States and numerous international countries.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
- Manufacturer
- Clarity Medical Systems Inc
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 (4)
- no lot numbers: RetCam 3 (RC3
- Part number 21-100500
- Part number 23-00100
- Part number 20-000300
Distribution
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