Recall Z-2459-2008 ยท GWQ Full-Montage Standard Electroencephalograph
Cardinal Health NeuroCare Division
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.
| Date | Sep 23, 2008 (initiated Jun 13, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| 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. |
| Quantity | 274 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991054 | BRAVO MULTI-MODALITY SYSTEM Nicolet Biomedical, Inc., Nov 3, 1999 |