Lumi 8 Intense LED Light Facial System, Sybaritic, Inc.,9220 James Ave South Minneapolis, Minnesota 55431., Mode of Oper

FDA device recall Z-1308-2009 · posted 2009-04-30 · Terminated

Recall details

Recalling firm

Sybaritic, Inc

Reason for recall

Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

Action taken

Letter sent to consignee on June 18, 2008 confirming a phone conversation on June 18 regarding the required Field Correction of the device. The letter also described the changes to be performed by the local technician to be in compliance with the FDA. The customer was asked to allow the technician access to their LUMI 8 system; allow technician to replace the computer chips and owner's manual; give current LUMI 8 owner's manual to technician; and sign the work order provided by the technician. Questions should be directed to Fred Berg at 800-445-8418 or fberg@sybaritic.com.

Root cause

PMA

Status

Terminated

Product code

OHS

Quantity affected

1

Distribution

USA: MI

Date initiated

2008-06-18

Date posted

2009-04-30

Date terminated

2012-07-05

Location

Bloomington, MN