Medical Device Recall: Z-0001-2008

FDA Recalls dataset · Firm: Bio-Logic Systems Corp · Status: Terminated

Recall Action Class: N/A Date Initiated: 2007-07-26 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2008.

Recall Res Number
Z-0001-2008
Recalling Firm / Manufacturer
Bio-Logic Systems Corp
FEI Number
1419887
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-07-26
Date Posted
2007-11-03
Date Terminated
2009-08-12
Product Code
GWQ
Event Number
38473
Product Quantity
311 units
Product Description 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.
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.
Action Details 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.
Distribution Pattern Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia
Code Information / Serial Numbers 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.

Related Establishments / Registrations

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