Stille 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.
Recall
- Recall Number
- Z-0564-2010
- Event Number
- 53817
- Firm
- Stille AB Gardsvagen
- FEI Number
- 3003696170
- Product Code
- MMZ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 3, 2009
- Posted
- December 23, 2009
- Terminated
- December 10, 2010
- Address
- 14 Solna Sweden
Description
Stille 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.
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.
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.
Worldwide Distribution -- Including countries of USA and Canada.
68 units total