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.
FDA Recall Z-0887-2009 · Posted 2009-01-26
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Recalling FirmRegenesis Biomedical Inc
Recall StatusTerminated
Product CodeILX
Date Initiated2008-09-29
Date Terminated2009-07-08
Product Quantity7 units
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.
Firm Action
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.
Root Cause
Finished device change control
Distribution Pattern
WY, VA, and NC
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.
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