Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System
FDA device recall Z-0578-05 · posted 2005-03-09 · Terminated
Recall details
- Recalling firm
- Sybaritic, Inc
- Reason for recall
- Device is performing functions that are not cleared in the 510(k).
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IMI
- Quantity affected
- 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
- Date initiated
- 2005-01-05
- Date posted
- 2005-03-09
- Date terminated
- 2007-02-07
- Location
- Bloomington, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K024307) | Sybaritic, Inc. | 2003-07-02 |