Recall Z-0578-05 ยท IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Sybaritic, Inc
Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
| Date | Mar 9, 2005 (initiated Jan 5, 2005) |
| Status | Terminated |
| Reason | Device is performing functions that are not cleared in the 510(k). |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024307 | DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM Sybaritic, Inc., Jul 2, 2003 |