Recall Z-2256-2013 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. The CARESCAPE Monitor B650 is indicated for monitoring and recording
| Date | Sep 19, 2013 (initiated Jul 12, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported. |
| Root cause | Software design |
| Action | GE Healthcare sent an Important Product Information letter dated July 12, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. GE Healthcare will provide a software and hardware correction at no charge once it is available. We will contact you to arrange for this correction. If you have any questions regarding this notification, please contact Technical Support (1-800- 558-7044) or your local Service Representative |
| Quantity | 9466 (3261 US, 6205 OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of : AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV,NH, NH, NM, NY, NC, OH, OK OR, PA, PR, SC, TN, TX, VA, WA, WV, WI and WY., and the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102239 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Oct 18, 2010 |