NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. Th
FDA device recall Z-2459-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Cardinal Health NeuroCare Division
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 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.
- Date initiated
- 2008-06-13
- Date posted
- 2008-09-23
- Date terminated
- 2011-12-11
- Location
- Madison, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAVO MULTI-MODALITY SYSTEM (K991054) | Nicolet Biomedical, Inc. | 1999-11-03 |