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Recall Observatory FDA recall evidence

Device product

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

Z-1894-2017

March 08, 2017

Class II

Product summary

Firm
Sonesta Medical Ab
Event
Event 77075
Status
Terminated
Classification
Class II
Quantity
28 devices
Official record key
device-enforcement:Z-1894-2017

Official wording

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

Code information: 12-00001-110V 12-00011-110V 23-00002-220V (Demo Product) 12-00002-110V 12-00012-110V 23-00001-220V 12-00003-110V 12-00013-110V 23-00003-220V 12-00004- 110V 12-00014-110V 23-00004-220V 12-00005-110V 12-00015-110V 23-00005-220V 12-00006-110V 12-20001-110V 23-00006-220V 12-00007-110V 12-20002-110V 23-00009-220V 12-00008-110V 12-20003-110V 23-00020-220V 12-00009-110V 12-20004 -110V 23-20001-220V 12-00010-110V 23-20002-220V

Distribution pattern: Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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