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U.S. Department of Health and Human Services

Class 2 Device Recall Cronus

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 Class 2 Device Recall Cronussee related information
Date Initiated by FirmJanuary 27, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on October 31, 2005
Recall NumberZ-0595-04
Recall Event ID 28254
510(K)NumberK021363 
Product Classification unknown device name - Product Code NFN
ProductCronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
Code Information Lot 0212-2027
Recalling Firm/
Manufacturer
Stereotaxis Inc
4041 Forest Park Ave
Saint Louis MO 63108-3213
For Additional Information ContactRobert W. Calllahan
314-615-6923
Manufacturer Reason
for Recall
The magnet at the end of the guidewire could break off.
FDA Determined
Cause 2
Other
ActionConsignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees.
Quantity in Commerce44 guidewires
DistributionThe product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.

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 = NFN
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