Recall Z-1930-2011 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 intrahospital 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 of
| Date | Apr 8, 2011 (initiated Mar 23, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off alarm in specific cases. 1. When the CARESCAPE Monitor is used to measure Cardiac Output values with the Patient Data Module (PDM) or TRAM Module, Cardiac Output values may be calculated incorrectl |
| Root cause | Software design |
| Action | The firm, GE Healthcare, sent "Urgent Medical Device Correction" letters dated March 23, 2011 to its consignees/customers. The letters were addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letters described the Safety Issues, Safety Instructions, Affected Product Details, Product Correction, and Contact Information. The customers were instructed to follow the safety instructions documented in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available and will c |
| Quantity | 1443 |
| Distribution | AL, AZ, AR, CA, CO, CT, FL,GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA,PR, SC, TN,TX, UT, VA, WA, WV, WI. UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SWITZERLAND, SWEDEN SLOVENIA, SLOVAKIA, SPAIN, SINGAPORE, SAUDI ARABIA, QATAR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102239 | CARESCAPE MONITOR B650 GE Healthcare Finland Oy, Oct 18, 2010 |