Recall Z-0887-2009 ยท ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Regenesis Biomedical Inc
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 wo
| Date | Jan 26, 2009 (initiated Sep 29, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Finished device change control |
| 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. |
| Quantity | 7 units |
| Distribution | WY, VA, and NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972093 | REGENESIS MODEL 42 Regenesis Biomedical, Inc., Oct 21, 1997 |