Recall Z-0285-2009 ยท DSI Detector And Alarm, Arrhythmia
GE Healthcare
GE Healthcare Solar 8000M System, a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients, within a hospital or facility environment
| Date | Jan 5, 2009 (initiated Apr 2, 2008) |
| Status | Terminated |
| Reason | A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of monitoring. It has not been observed in other monitoring applications. The software error will result in a reset of the Solar 8000M/i, causing a loss of monitoring for approximately 1-2 minutes a |
| Root cause | Software design |
| Action | A GE Healthcare consignee letter was sent out 9/9/08. The letter dated August 26, 2008 was addressed to Healthcare Administrator/Risk Manger. The letter described the problem, product and provided recommendation. |
| Quantity | 2782 |
| Distribution | Nationwide to: AL, AR, AZ, CA, FL, GA, IA, ID, IL, IN, MA, MI, MN, MO, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, and WI. OUS to include: Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, France, Germany, Indonesia, Ireland, Italy, Jordan, Korea, Lebanon, Lithuania, Malaysia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012467 | SOLAR 8000M SYSTEM General Electric Medical Systems Information Techn, Feb 11, 2002 |