Events

Recall of Device Recall SlimLine

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybaritic, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51716
  • Event Risk Class
    Class 2
  • Event Number
    Z-1423-2009
  • Event Initiated Date
    2008-06-18
  • Event Date Posted
    2009-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81064
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    body chamber - Product Code ISA
  • Reason
    Misbranded and sale without pre-market notification.
  • Action
    Sybaritic sent a letter to the consignee on June 18, 2008. The letter confirmed their phone conversation on June 16 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.

Device

Device Recall SlimLine
  • Model / Serial
    Serial Number 2109257
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    UT
  • Product Description
    Sybaritic, Inc., SlimLine Health Environment Capsule, || a dry heat body chamber with facial and body chamber LED panels.
  • Manufacturer
    Sybaritic, Inc

Manufacturer

Sybaritic, Inc
  • Manufacturer Address
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA