Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer C
FDA device recall Z-1073-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Gyrus ACMI Corporation
- Reason for recall
- Sterilization Instructions not adequate for sterilizing.
- Action taken
- 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
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 53 units
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-05-23
- Date posted
- 2007-08-09
- Date terminated
- 2010-05-25
- Location
- Southborough, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER (K052135) | Cybersonics, Inc. | 2005-12-20 |