Medical device recalls Moderate risk

YAMAHA MOTOR CORPORATION recalls Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10,…

Recall date
April 17, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1815-2024
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

Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

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