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Class 2 Device Recall Sonesta 6303 |
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Date Initiated by Firm |
November 03, 2009 |
Date Posted |
December 23, 2009 |
Recall Status1 |
Terminated 3 on December 10, 2010 |
Recall Number |
Z-0566-2010 |
Recall Event ID |
53817 |
Product Classification |
Electric Cystometric Table - Product Code MMZ
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Product |
Stille Sonesta Gynecology and Urology Table 6303 ; 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 6303, serial numbers 12-11076, 12-11077, 12-11078, 12-11079, 12-11080, 12-11081, 12-11082, 12-11083, 12-11084, 12-11086, 12-11127, 12-11129, 12-11133, 12-11134, 12-11137, 12-11141, 12-11145, 12-11273, 12-11274; tables sold between 3/24/09 and 9/30/09 |
Recalling Firm/ Manufacturer |
Stille AB Gardsvagen 14 Solna Sweden
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For Additional Information Contact |
800-655-1614
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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.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Stille 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 Commerce |
68 units total |
Distribution |
Worldwide Distribution -- Including countries of USA and Canada. |
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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