Events

Recall of Device Recall Dermonosonic NonInvasive Subdermal Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybaritic, 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
    30792
  • Event Risk Class
    Class 2
  • Event Number
    Z-0578-05
  • Event Initiated Date
    2005-01-05
  • Event Date Posted
    2005-03-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36608
  • 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
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat - Product Code IMI
  • Reason
    Device is performing functions that are not cleared in the 510(k).
  • Action
    The firm initiated the recall procedure 01/05/05. A phone call is made to each facility which has a dermosonic machine. The phone call serves the purpose of telling the customer that their dermosonic machine needs a programming chip replaced, the manual updated and a 'caution' sticker be placed on the machine. An employee of Computer Repair.com then contacts the customer to set up a time to replace the programming chip and manual, and place a 'caution' sticker on the machine.

Device

Device Recall Dermonosonic NonInvasive Subdermal Therapy System
  • Model / Serial
    serial numbers: 8, 960, 1341, 1343, 1344, 1351 through 1354, 1359, 1363, 1365 through 1368, 1372,  1379, 1581, 1583, 1584, 1589 through 1593, 1598, 1599, 1756, 1757, 1760, 1771,  1784, 1786, 1792, 1793, 2001, 2005, 2007, 2012 through 2018, 2020 through 2025, 2028, 2029, 2031, 2032, 2036, 2037, 2038, 2041, 2043, 2044, 2047,  2175, 2176, 2177, 2180 through 2187, 2189 through 2195, 2197, 2198, 2348, 2355 through 2370, 2372, 2373, 2374, 2375, 2376, 2378, 2381, 2382,  2389, 2390, 2392, 2393, 2400 through 2433, 2435, 2436, 2442, 2443, 2453, 2475, 2560,  2562, 2563, 2564, 2565, 2566, 2568, 2569, 2572 through 2579, 2590, 2592, 2593, 2595, 2596, 2597, 2598, and 2599
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, CO, CT, FL, GA, ID, IL, IA, KS, LA, MA, MI, MN, NV, NJ, NM, NY, NC, OH, OK, OR, SC, SD, TN, TX, UT, VA & WI and to the Phillipines
  • Product Description
    Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
  • Manufacturer
    Sybaritic, Inc

Manufacturer

Sybaritic, Inc
  • Manufacturer Address
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA