FDA Recall Terminated

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)

Recall: Z-0761-2007 · Initiated February 26, 2007

Recall

Recall Number
Z-0761-2007
Event Number
37518
Firm
Bio-Logic Systems Corp
FEI Number
1419887
Product Code
GWQ
Status
Terminated
Root Cause
Other
Initiated
February 26, 2007
Posted
April 20, 2007
Terminated
August 26, 2008
Address
1 Bio Logic Plz, Mundelein, IL, 60060-3708

Description

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)

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.

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.

Distribution

Worldwide, USA , Canada, China, Hong Kong, India and Israel.

Quantity

130 battery packs (112 domestic USA, 18 foreign)