Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed-power output radio frequency generator and transmitter designed to operate at the FCC authorized medical device frequency of 27.12 MHz. Provant transmits a fixed dose of non-ionizing, non-thermal RF energy via an applicator pad that is placed adjacent to the patient's dressed wound. The Provant Wound Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
This recall has been terminated (originally issued January 26, 2009).
- Company
- Regenesis Biomedical Inc
- Recall Initiated
- September 29, 2008
- Posted
- January 26, 2009
- Terminated
- July 8, 2009
- Recall Number
- Z-0887-2009
- Quantity
- 7 units
- Firm Location
- Scottsdale, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the effectiveness of Provant therapy may be impaired.
Distribution
WY, VA, and NC
Lot / Code Info
Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
Root Cause
Finished device change control
Action Taken
Written notification dated September 29, 2008 was sent to consignees by overnight mail notifying them of the nonconformance and providing instructions for return of the affected PROVANT Model 4201A units to Regenesis. Receipt of the notification and return shipping of the units will be verified. Contact Regenesis Biomedical Inc. for additional information at 1-480-970-4970.