Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0761-2007

Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060...

Bio-Logic Systems Corp. / initiated 2007-02-26 / Terminated

Bio-Logic Systems Corp began a recall of Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-T2ASM2. (a Digital EEG/Sleep Recorder... on . The reason FDA records is "Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0761-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bio-Logic Systems Corp.
Product
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)
Product code
GWQ Full-Montage Standard Electroencephalograph
Reason for recall
Battery and Battery Compartment; incorrect placement in the Netlink Traveler unit which caused a short in the wiring of the battery pack and overheating.
FDA 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 in commerce
130 battery packs (112 domestic USA, 18 foreign)
Distribution
Worldwide, USA , Canada, China, Hong Kong, India and Israel.
Product codes and lots
all battery packs with part number 520-LIBAT4-2