Welch Allyn vision screener display may flicker inducing photosensitive seizures
Baxter is recalling the Welch Allyn Spot Vision Screener VS100 on software version 3.2.0.1 because the display screen may unintentionally flicker, which may induce photosensitive seizure activity.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source states flickering may induce seizure activity in susceptible individuals, and no injuries are stated.
Plain-English summary
Baxter Healthcare Corporation is recalling the Welch Allyn Spot Vision Screener VS100, an ophthalmic refractometer, running software version 3.2.0.1. About 59 units were distributed across 14 US states and to Colombia and India. The FDA has classified this recall as Class II.
The display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Affected product carries primary DI 00732094214154 and packaging DI 00732094212228, across the serial numbers listed in the FDA enforcement record.
Facilities can identify affected units by the model and software version above, and may contact Baxter Healthcare Corporation for further information.
The recalled product
- Product
- Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version: Software version 3.2.0.1 Product Description: Welch Allyn Spot Vision Screener VS100, FDA product code name: Refractometer, ophthalmic One unit…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 59
Distribution
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