FDA Medical Device Recalls (openFDA)
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)
- Recall number
- Z-0761-2007
- 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)
- Status
- Terminated
- Initiated
- 2007-02-26
- Posted
- 2007-04-20
- Terminated
- 2008-08-26
- 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.
- Lot, serial or model codes
- all battery packs with part number 520-LIBAT4-2
- 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