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Terminated

NicoletOne photic adapter cable 085-463700

FDA Recall Z-2389-2008 · Posted 2008-09-21

Recalling FirmCardinal Health NeuroCare Division
Recall StatusTerminated
Product CodeGWQ
Date Initiated2008-06-05
Date Terminated2010-10-13
Product Quantity92

Reason for Recall

Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi

Firm Action

A "Cardinal Health Urgent: Medical Device Correction" letter was sent to consignees. The letter described the product and the problem. The consignees were asked to confirm completion of the cable exchange by returning an information card. If you have questions, contact Cardinal Health (formerly VIASYS) NeuroCare Technical Support Group at 1-800-356-0007 (US), 608-273-5000 (OUS) or email [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

CA FL GA ID IN LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico Netherlands Russia Saudi Arabia Slovenia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991054BRAVO MULTI-MODALITY SYSTEMNicolet Biomedical, Inc. · 1999-11-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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