Medical device recalls Moderate risk

Sonesta Medical Ab recalls Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

Recall date
March 8, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1894-2017
FDA classification
Class II
Brand / firm
Sonesta Medical Ab
Sold / distributed
Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy

Why it was recalled

The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.

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

What was recalled

Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

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