Z-0001-2008

Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and...

Name: Z-0001-2008 Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and...
Creator: Bio-Logic Systems Corp
Published: 2007-07-26
License: https://open.fda.gov/license/

Bio-Logic Systems Corp. / initiated 2007-07-26 / Terminated / root cause: design

FDA source

Bio-Logic Systems Corp began a recall of Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems... on 2007-07-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0001-2008
Status: Terminated
Initiated: 2007-07-26
Posted: 2007-11-03
Terminated: 2009-08-12
Recalling firm: Bio-Logic Systems Corp.
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.
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
Root cause tag: design
FDA root cause: 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
Product codes and lots: 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.

Product code GWQ

K052066Class IICeegraph/sleepscan Netlink TravelerBio-Logic Systems Corp. / cleared 2005-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)