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U.S. Department of Health and Human Services

Class 2 Device Recall Dermonosonic NonInvasive Subdermal Therapy System

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  Class 2 Device Recall Dermonosonic NonInvasive Subdermal Therapy System see related information
Date Initiated by Firm January 05, 2005
Date Posted March 09, 2005
Recall Status1 Terminated 3 on February 07, 2007
Recall Number Z-0578-05
Recall Event ID 30792
510(K)Number K024307  
Product Classification Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat - Product Code IMI
Product Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
Code Information 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 
Recalling Firm/
Manufacturer		 Sybaritic, Inc
9220 James Ave S
Bloomington MN 55431-2302
For Additional Information Contact Steve Trinter
952-888-8282 Ext. 749
Manufacturer Reason
for Recall		 Device is performing functions that are not cleared in the 510(k).
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IMI and Original Applicant = SYBARITIC, INC.
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