Events

Recall of Regenesis Biomedical PROVANT Wound

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Regenesis Biomedical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50230
  • Event Risk Class
    Class 2
  • Event Number
    Z-0887-2009
  • Event Date Posted
    2009-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75023
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    diathermy, shortwave - Product Code ILX
  • 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.
  • 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.

Device

Regenesis Biomedical PROVANT Wound
  • Model / Serial
    Serial Numbers: 704, 920, 460, 709, 711, 714, and 727
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    WY, VA, and NC
  • Product Description
    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.
  • Manufacturer
    Regenesis Biomedical Inc

Manufacturer

Regenesis Biomedical Inc
  • Manufacturer Address
    Regenesis Biomedical Inc, 1435 N Hayden Rd, Scottsdale AZ 85257-3773
  • Manufacturer Parent Company (2017)
    Regenesis Biomedical
  • Source
    USFDA