Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RetCam 3 Recalled by Clarity Medical Systems Inc Due to Software anomaly for RetCam 3, RetCam Shuttle and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Clarity Medical Systems Inc directly.
Affected Products
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.
Quantity: 166 Ret Cam Shuttles, 288 RetCam 3 and 23 RetCam Portables.
Why Was This Recalled?
Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Clarity Medical Systems Inc
Clarity Medical Systems Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report