Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
FDA device recall Z-1404-2010 · posted 2010-04-16 · Terminated
Recall details
- Recalling firm
- Novasys Medical Inc
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- NVJ
- Quantity affected
- 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) .
- Date initiated
- 2009-07-27
- Date posted
- 2010-04-16
- Date terminated
- 2011-01-08
- Location
- Newark, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVASYS TRANSURETHRAL RF SYSTEM (K042132) | Novasys Medical, Inc. | 2004-12-21 |