Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Bio-logic Systems Corp., a nebus company, Mundelein, IL 60060; Model 580-
FDA device recall Z-0761-2007 · posted 2007-04-20 · Terminated
Recall details
- Recalling firm
- Bio-Logic Systems Corp
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 130 battery packs (112 domestic USA, 18 foreign)
- Distribution
- Worldwide, USA , Canada, China, Hong Kong, India and Israel.
- Date initiated
- 2007-02-26
- Date posted
- 2007-04-20
- Date terminated
- 2008-08-26
- Location
- Mundelein, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEEGRAPH/SLEEPSCAN NETLINK TRAVELER (K052066) | Bio-Logic Systems Corp. | 2005-08-26 |