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.
This recall has been terminated (originally issued December 23, 2009).
- Company
- Stille Ab Gardsvagen
- Recall Initiated
- November 3, 2009
- Posted
- December 23, 2009
- Terminated
- December 10, 2010
- Recall Number
- Z-0566-2010
- Quantity
- 68 units total
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- Including countries of USA and Canada.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.