Z-0566-2010

Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden...

Name: Z-0566-2010 Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden...
Creator: Stille AB
Published: 2009-11-03
License: https://open.fda.gov/license/

Stille AB / initiated 2009-11-03 / Terminated / root cause: manufacturing process

FDA source

Stille AB began a recall of Stille Sonesta Gynecology and Urology Table 6303 ; an electric cystometric table; Stille AB, Solna, Sweden. Used to position the subject/patient in a desired... on 2009-11-03. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0566-2010
Status: Terminated
Initiated: 2009-11-03
Posted: 2009-12-23
Terminated: 2010-12-10
Recalling firm: Stille AB
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.
Product code: MMZ Table, Cystometric, Electric
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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

Product code MMZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)