Recall Z-0564-2010 ยท MMZ Table, Cystometric, Electric
Stille AB
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.
| Date | Dec 23, 2009 (initiated Nov 3, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 ack |
| Quantity | 68 units total |
| Distribution | Worldwide Distribution -- Including countries of USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.