FDA Medical Device Recalls (openFDA)
Novasys Medical Inc: Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
- Recall number
- Z-1404-2010
- Recalling firm
- Novasys Medical Inc
- Product
- Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA
- Status
- Terminated
- Initiated
- 2009-07-27
- Posted
- 2010-04-16
- Terminated
- 2011-01-08
- 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) .
- Lot, serial or model codes
- Issue affects all lots in distribution.
- 510(k) numbers
- ["K042132"]
- PMA numbers
- not on file
- Product code
- NVJ
- Firm FEI
- 3003647794
- Firm city
- Newark
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28