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U.S. Department of Health and Human Services

Class 2 Device Recall Renessa RF System

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  Class 2 Device Recall Renessa RF System see related information
Date Initiated by Firm July 27, 2009
Date Posted April 16, 2010
Recall Status1 Terminated 3 on January 08, 2011
Recall Number Z-1404-2010
Recall Event ID 53031
510(K)Number K042132  
Product Classification Applicator, transurethral, radio frequency, for stress urinary incontinence in women - Product Code NVJ
Product Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
Code Information Issue affects all lots in distribution.
Recalling Firm/
Manufacturer		 Novasys Medical Inc
39684 Eureka Dr
Newark CA 94560-4805
For Additional Information Contact Charles S. Carignan, MD
510-226-4060
Manufacturer Reason
for Recall		 Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation
FDA Determined
Cause 2		 Labeling design
Action A Field Action notification letter was sent to all current customers (physicians) along with the revised instructions for use, and a small supply of the revised patient information brochures. The company also updated physician information brochures and patient/physician DVDs to include the information. This was shipped to physicians in August/September of 2009. Additional copies of the Patient Brochures can be ordered by contacting Novasys Customer Service at 866-784-4777. Questions should be addressed to the firm at the same telephone number.
Quantity in Commerce As of 6/12/09 there were 436 Probes at customer accounts.
Distribution US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = NVJ and Original Applicant = NOVASYS MEDICAL, INC.
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