FDA-Device2017-05-10Class II

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

Sonesta Medical Ab
Hazard

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

Sold states
Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
Affected count
28 devices
Manufactured in
Adolfsbergsvagen 31, Bromma, Sweden
Products
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1894-2017

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