Recall Z-1073-2007 ยท FFK Lithotriptor, Electro-Hydraulic
Gyrus ACMI Corporation
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
| Date | Aug 9, 2007 (initiated May 23, 2007) |
| Status | Terminated |
| Reason | Sterilization Instructions not adequate for sterilizing. |
| Root cause | Other |
| 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. |
| Quantity | 53 units |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER Cybersonics, Inc., Dec 20, 2005 |