Stille Sonesta Gynecology and Urology Table 6302 and 6302U; an electric cystometric table; Stille AB, Solna, Sweden. Use

FDA device recall Z-0565-2010 · posted 2009-12-23 · Terminated

Recall details

Recalling firm

Stille AB

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MMZ

Quantity affected

68 units total

Distribution

Worldwide Distribution -- Including countries of USA and Canada.

Date initiated

2009-11-03

Date posted

2009-12-23

Date terminated

2010-12-10

Location

Solna, Sweden