Medical device recalls Moderate risk

YAMAHA MOTOR CORPORATION recalls Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

Recall date
April 17, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1816-2024
FDA classification
Class II
Brand / firm
YAMAHA MOTOR CORPORATION
Sold / distributed
US Nationwide

Why it was recalled

Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

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