Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System

FDA Recall Z-0578-05 · Posted 2005-03-09

Recalling FirmSybaritic, Inc
Recall StatusTerminated
Product CodeIMI
Date Initiated2005-01-05
Date Terminated2007-02-07
Product Quantity185 units

Reason for Recall

Device is performing functions that are not cleared in the 510(k).

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024307DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEMSybaritic, Inc. · 2003-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑