Recall Z-1404-2010 ยท NVJ Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women
Novasys Medical Inc
Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
| Date | Apr 16, 2010 (initiated Jul 27, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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) . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042132 | NOVASYS TRANSURETHRAL RF SYSTEM Novasys Medical, Inc., Dec 21, 2004 |