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U.S. Department of Health and Human Services

Class 2 Device Recall Sonesta S2

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 Class 2 Device Recall Sonesta S2see related information
Date Initiated by FirmMarch 08, 2017
Create DateApril 28, 2017
Recall Status1 Terminated 3 on August 20, 2019
Recall NumberZ-1894-2017
Recall Event ID 77075
Product Classification Table, cystometric, electric - Product Code MMZ
ProductSonesta S2; Article numbers: 525-S2-110V and 525S2-220V
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
FEI Number 3010496070
Recalling Firm/
Manufacturer		 Sonesta Medical Ab
Adolfsbergsvagen 31
Bromma Sweden
For Additional Information Contact
512-327-9997
Manufacturer Reason
for Recall		The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
FDA Determined
Cause 2		Labeling mix-ups
ActionSonesta notified customers (distributors) on March 8, 2017, of the faulty labeling. Corrected labeling was sent to customers, they were requested to apply the new labels and confirm that the correction was implemented. For further information regarding this recall, please call (512) 327-9997.
Quantity in Commerce28 devices
DistributionWorldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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