Z-0578-05

Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System

Name: Z-0578-05 Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
Creator: Sybaritic, Inc
Published: 2005-01-05
License: https://open.fda.gov/license/

Sybaritic, Inc. / initiated 2005-01-05 / Terminated

FDA source

Sybaritic, Inc began a recall of Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System on 2005-01-05. The reason FDA records is "Device is performing functions that are not cleared in the 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0578-05
Status: Terminated
Initiated: 2005-01-05
Posted: 2005-03-09
Terminated: 2007-02-07
Recalling firm: Sybaritic, Inc.
Product: Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
Product code: IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Reason for recall: Device is performing functions that are not cleared in the 510(k).
FDA root cause: Other
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.
Quantity in commerce: 185 units
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 codes and lots: 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 code IMI

K024307Class IIDermosonic Non-Invasive Subdermal Therapy SystemSybaritic, Inc. / cleared 2003-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)