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U.S. Department of Health and Human Services

Class 2 Device Recall Ceegraph/Sleepscan Netlink Traveler

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 Class 2 Recall
Ceegraph/Sleepscan Netlink Traveler
see related information
Date Posted April 20, 2007
Recall Status1 Terminated on August 26, 2008
Recall Number Z-0761-2007
Recall Event ID 37518
Premarket Notification
510(K) Number
K052066 
Product Classification Full-Montage Standard Electroencephalograph - Product Code GWQ
Product 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)
Code Information all battery packs with part number 520-LIBAT4-2
Recalling Firm/
Manufacturer
Bio-Logic Systems Corp
1 Bio Logic Plz
Mundelein, Illinois 60060-3708
For Additional Information Contact Mr. Jorge Artiles
650-802-0400
Manufacturer Reason
for Recall
Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 130 battery packs (112 domestic USA, 18 foreign)
Distribution Worldwide, USA , Canada, China, Hong Kong, India and Israel.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = BIO-LOGIC SYSTEMS CORP.
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