Welch Allyn Spot Vision Screener VS100 Software Issue May Cause Screen Flicker Triggering Seizures

FDA issued a Class II medical device recall for Welch Allyn Spot Vision Screener VS100 models running software version 3.2.0.1. The recall addresses a software defect causing the display screen to flicker unintentionally, which may trigger photosensitive seizure activity in susceptible individuals. The affected devices were distributed to 15 US states and internationally to Colombia and India.\n\nHealthcare providers and facilities using these vision screening devices should immediately assess their inventory for affected units, discontinue clinical use pending software correction or device replacement, and monitor FDA communications for updated remediation instructions. This recall affects medical device manufacturers and healthcare providers performing vision screening examinations, particularly pediatric and population health screening programs where these devices are commonly deployed.