Date Initiated by Firm |
March 08, 2017 |
Create Date |
April 28, 2017 |
Recall Status1 |
Terminated 3 on August 20, 2019 |
Recall Number |
Z-1894-2017 |
Recall Event ID |
77075 |
Product Classification |
Table, cystometric, electric - Product Code MMZ
|
Product |
Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V |
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 |
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 |
Action |
Sonesta 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 Commerce |
28 devices |
Distribution |
Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy |
Total Product Life Cycle |
TPLC Device Report
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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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