Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
FDA Recall Z-1404-2010 · Posted 2010-04-16
Advertisement
Recalling FirmNovasys Medical Inc
Recall StatusTerminated
Product CodeNVJ
Date Initiated2009-07-27
Date Terminated2011-01-08
Product QuantityAs of 6/12/09 there were 436 Probes at customer accounts.
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
Firm 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.
Root Cause
Labeling design
Distribution Pattern
US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement