NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room.
FDA Recall Z-2459-2008 · Posted 2008-09-23
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Recalling FirmCardinal Health NeuroCare Division
Recall StatusTerminated
Product CodeGWQ
Date Initiated2008-06-13
Date Terminated2011-12-11
Product Quantity274
Reason for Recall
NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Cardinal Health NeuroCare has confirmed that the 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.
Firm Action
Consignees were sent a "Cardinal Health Urgent: Medical Device Correction" letter dated June 23, 2008. The letter identified the product and problem. It also provided instructions (Field Correction) to install the software patch and requested return of the verification form. Contact Cardinal Health NeuroCare Division at 1-608-271-3333 for assistance.
Root Cause
Software design
Distribution Pattern
US: AL, AR, CA, CO, FL, GA, IL IN, KY, LA, MO MS, NC, NJ, NY, OH, PA, TN, TX, WA, and WI. OUS: CH, CN, DK, GB, HK, IN, NO, RU, and UK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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