FDA Medical Device Recalls (openFDA)
Bio-Logic Systems Corp: 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.
- Recall number
- Z-0001-2008
- 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.
- Status
- Terminated
- Initiated
- 2007-07-26
- Posted
- 2007-11-03
- Terminated
- 2009-08-12
- Reason
- 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
- 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
- 311 units
- Distribution
- Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K052066"]
- PMA numbers
- not on file
- Product code
- GWQ
- Firm FEI
- 1419887
- Firm city
- Mundelein
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28