Events

Recall of Device Recall Ceegraph/Sleepscan Netlink Traveler

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bio-Logic Systems Corp.

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
    37518
  • Event Risk Class
    Class 2
  • Event Number
    Z-0761-2007
  • Event Initiated Date
    2007-02-26
  • Event Date Posted
    2007-04-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50670
  • 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
    Electroencephalograph - Product Code GWQ
  • Reason
    Battery and battery compartment; incorrect placement in the netlink traveler unit which caused a short in the wiring of the battery pack and overheating.
  • Action
    On 2/26/07, Bio-logic Systems shipped replacement batteries, marked with part number 520-LIBAT4-3 and a label reading 'THIS SIDE OUT', and a new battery compartment cover with a label inside the cover to clarify the correct installation of the battery to each of the affected customers. The accounts were requested to remove and replace the old batteries, part 520-LIBTA4-2, and compartment covers, and return the old batteries and covers to Bio-logic Systems in the enclosed pre-paid shipping container, along with the completed accounting form.

Device

Device Recall Ceegraph/Sleepscan Netlink Traveler
  • Model / Serial
    all battery packs with part number 520-LIBAT4-2
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA , Canada, China, Hong Kong, India and Israel.
  • Product Description
    Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG)
  • Manufacturer
    Bio-Logic Systems Corp

Manufacturer

Bio-Logic Systems Corp
  • Manufacturer Address
    Bio-Logic Systems Corp, 1 Bio Logic Plz, Mundelein IL 60060-3708
  • Source
    USFDA