Recall Z-0761-2007 ยท GWQ Full-Montage Standard Electroencephalograph
Bio-Logic Systems Corp
Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG)
| Date | Apr 20, 2007 (initiated Feb 26, 2007) |
| Status | Terminated |
| Reason | Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating. |
| Root cause | Other |
| Action | On 2/26/07, Bio-logic Systems shipped replacement batteries, marked with part number 520-LIBAT4-3 and a label reading 'THIS SIDE OUT', and a new battery compartment cover with a label inside the cover to clarify the correct installation of the battery to each of the affected customers. The accounts were requested to remove and replace the old batteries, part 520-LIBTA4-2, and compartment covers, and return the old batteries and covers to Bio-logic Systems in the enclosed pre-paid shipping container, along with the completed accounting form. |
| Quantity | 130 battery packs (112 domestic USA, 18 foreign) |
| Distribution | Worldwide, USA , Canada, China, Hong Kong, India and Israel. |
| 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 |