Recall Z-0001-2008 ยท GWQ Full-Montage Standard Electroencephalograph
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 Ipe
| Date | Nov 3, 2007 (initiated Jul 26, 2007) |
| Status | Terminated |
| 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 enclo |
| Quantity | 311 units |
| Distribution | Worldwide Distribution -- USA and China, Egypt, Hong Kong, Israel, Malaysia and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052066 | CEEGRAPH/SLEEPSCAN NETLINK TRAVELER Bio-Logic Systems Corp., Aug 26, 2005 |