Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound Therapy System is a solid-state, fixed
FDA device recall Z-0887-2009 · posted 2009-01-26 · Terminated
Recall details
- Recalling firm
- Regenesis Biomedical Inc
- 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.
- 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.
- Root cause
- Finished device change control
- Status
- Terminated
- Product code
- ILX
- Quantity affected
- 7 units
- Distribution
- WY, VA, and NC
- Date initiated
- 2008-09-29
- Date posted
- 2009-01-26
- Date terminated
- 2009-07-08
- Location
- Scottsdale, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REGENESIS MODEL 42 (K972093) | Regenesis Biomedical, Inc. | 1997-10-21 |