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U.S. Department of Health and Human Services

Class 2 Device Recall Gyrus CyberWand

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 Class 2 Device Recall Gyrus CyberWandsee related information
Date Initiated by FirmMay 23, 2007
Date PostedAugust 09, 2007
Recall Status1 Terminated 3 on May 25, 2010
Recall NumberZ-1073-2007
Recall Event ID 37999
510(K)NumberK052135 
Product Classification Ultrasonic Lithotripter - Product Code FFK
ProductGyrus 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
Code Information Product distributed prior to May 7, 2007.
FEI Number 3003790304
Recalling Firm/
Manufacturer		 Gyrus ACMI Corporation
136 Turnpike Road
Southborough MA 01772-2118
For Additional Information Contact
508-804-2600
Manufacturer Reason
for Recall		Sterilization Instructions not adequate for sterilizing.
FDA Determined
Cause 2		Other
ActionGyrus 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 in Commerce53 units
DistributionNationwide and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FFK
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