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U.S. Department of Health and Human Services

Class 2 Device Recall Sonesta 6202

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 Class 2 Device Recall Sonesta 6202see related information
Date Initiated by FirmNovember 03, 2009
Date PostedDecember 23, 2009
Recall Status1 Terminated 3 on December 10, 2010
Recall NumberZ-0564-2010
Recall Event ID 53817
Product Classification Electric Cystometric Table - Product Code MMZ
ProductStille Sonesta Urodynamic Table 6202 Gynecology/Urology Procedure Chair; an electric cystometric table; Stille AB, Solna, Sweden. Used to position the subject/patient in a desired position during urodynamic, general examinations, cystoscopy, ultrasound, biofeedback, vasectomy and OBGYN procedures.
Code Information Model 6202, serial numbers 12-30396, 12-30397, 12-30398, 12-30399, 12-30400, 12-30401, 12-30402, 12-30403, 12-30404, 12-30405, 12-30406, 12-30410, 12-30411, 12-30412, 12-30413, 12-30414, 12-30415, 12-30416, 12-30417, 12-30418, 12-30419, 12-30420, 12-30421, 12-30422, 12-30424, 12-30425, 12-30426, 12-30427, 12-30428, 12-30429, 12-30431, 12-30432, 12-30433; tables sold between 3/24/09 and 9/30/09
FEI Number 3003696170
Recalling Firm/
Manufacturer		 Stille AB
Gardsvagen 14
Solna Sweden
For Additional Information Contact
800-655-1614
Manufacturer Reason
for Recall		There is a potential hazard to the patient if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionStille sent Field Safety Notices dated 10/30/09 to the direct accounts, informing them that there is a potential hazard with the Sonesta tables if the bolts holding the side rail break, causing the accessories attached at the side rails of the tables and chairs to fall off during a medical procedure. Stille developed a retrofit kit consisting of six side rail bolts and instructions for installing the bolts, which were sent to the end users with the safety notice. The accounts were requested to replace the side rail bolts with the new bolts provided, and to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 12/11/09. Contact Stille Surgical Inc. at 224-612-5404 for assistance.
Quantity in Commerce68 units total
DistributionWorldwide Distribution -- Including countries of USA and Canada.
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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