Recall Z-1175-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 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 CARESCAP
| Date | Mar 11, 2014 (initiated Feb 28, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Field Safety Notice dated February 26, 2014, to all International consignees. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issues and Instructions, Affected Product Details Product Correction and Contact Information ( Contact Technical Support at 1-800-558-7044 or their local Service Representative). GE Healthcare determined that there were no US sites affected since all units were under GE control therefore, no customer letter was deployed in US. F |
| Quantity | 676 units OUS |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM. |
| FDA record | Open on fda.gov |