Z-1894-2017 Class II Terminated

Recalled by Sonesta Medical Ab — Bromma

Recall Details

Product Type
Devices
Report Date
May 10, 2017
Initiation Date
March 8, 2017
Termination Date
August 20, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 devices

Product Description

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

Reason for Recall

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

Distribution Pattern

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

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