Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
- Company
- Sybaritic, Inc
- Recall Initiated
- January 5, 2005
- Posted
- March 9, 2005
- Terminated
- February 7, 2007
- Recall Number
- Z-0578-05
- Quantity
- 185 units
- Firm Location
- Bloomington, MN
Reason for Recall
Device is performing functions that are not cleared in the 510(k).
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
Lot / Code Info
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
Root Cause
Other
Action Taken
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.