FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0564-2010
- Recalling firm
- Stille AB
- Product
- 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.
- Status
- Terminated
- Initiated
- 2009-11-03
- Posted
- 2009-12-23
- Terminated
- 2010-12-10
- 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 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
- 68 units total
- Distribution
- Worldwide Distribution -- Including countries of USA and Canada.
- Lot, serial or model codes
- Model 6202, serial numbers 12-30396, 12-30397, 12-30398, 12-30399, 12-30400, 12-30401, 12-30402, 12-30403, 12-30404, 12-30405, 12-30406, 12-30410, 12-30411, 12-30412, 12-30413, 12-30414, 12-30415, 12-30416, 12-30417, 12-30418, 12-30419, 12-30420, 12-30421, 12-30422, 12-30424, 12-30425, 12-30426, 12-30427, 12-30428, 12-30429, 12-30431, 12-30432, 12-30433; tables sold between 3/24/09 and 9/30/09
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MMZ
- Firm FEI
- 3003696170
- Firm city
- Solna
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28