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Terminated

Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray

FDA Recall Z-1073-2007 · Posted 2007-08-09

Recalling FirmGyrus ACMI Corporation
Recall StatusTerminated
Product CodeFFK
Date Initiated2007-05-23
Date Terminated2010-05-25
Product Quantity53 units

Reason for Recall

Sterilization Instructions not adequate for sterilizing.

Firm Action

Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.

Root Cause

Other

Distribution Pattern

Nationwide and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052135CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTERCybersonics, Inc. · 2005-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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