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U.S. Department of Health and Human Services

Class 2 Device Recall Ceegraph/Sleepscan Netlink with Video

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  Class 2 Device Recall Ceegraph/Sleepscan Netlink with Video see related information
Date Initiated by Firm July 26, 2007
Date Posted November 03, 2007
Recall Status1 Terminated 3 on August 12, 2009
Recall Number Z-0001-2008
Recall Event ID 38473
510(K)Number K052066  
Product Classification Electroencephalograph - Product Code GWQ
Product Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Code Information Pole assembly 580-VIDPOL and 585-CYBPSM, used with Models 580-IPCART and 580-PNCART - the cart component of the Ceegraph/Sleepscan Netlink with Video. There are no serial numbers on the pole assembly.
Recalling Firm/
Manufacturer		 Bio-Logic Systems Corp
1 Bio Logic Plaza
Mundelein IL 60060-3708
For Additional Information Contact Customer Support
800-332-3114
Manufacturer Reason
for Recall		 Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.
FDA Determined
Cause 2		 Device Design
Action Bio-logic sent a Safety Alert letters dated 7/26/07 to the affected customers, warning them that using the pole to transport the cart may cause the weld at the base of the pole to weaken, causing it to break. As a precaution to ensure customer safety, the accounts were instructed to place the enclosed red sticker on the pole, below the tightening knob. An Instruction sheet is enclosed . The warning label reads: "Caution: Do not use as a handle to move cart. Always lower camera when transporting. Avoid sudden stops or collisions." The accounts were requested to complete and return an enclosed reply sheet acknowledging the receipt of the letter and the placement of the warning labels on the poles. Any questions were directed to Customer Support at 1-800-332-3114.
Quantity in Commerce 311 units
Distribution Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = BIO-LOGIC SYSTEMS CORP.
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