Recall Z-0823-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
| Date | Feb 14, 2013 (initiated Sep 30, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device. |
| Root cause | Software design |
| Action | GE Healthcare sent an Important Product Notification letteron September 30, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to keep the patient under close observation or use an alternate monitoring device. Customers should not disconnect the affected USB devices from the patient monitor during an active patient case. If the license is enabled, the alarm limit adjustments from the iCentral Client has an L-NETM-00 license should be disabled. GE Healthcare would contact customers to sched |
| Quantity | 2813 |
| Distribution | Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102239 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Oct 18, 2010 |