Recall Z-1147-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medica
| Date | Mar 6, 2014 (initiated Feb 13, 2014) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AV |
| Root cause | Software design |
| Action | GE Healthcare sent a "Urgent Medical Device Correction" letter dated February 12, 2014. The letter was sent to all affected customers. It identified the product the problem and the action needed to be taken by the customers. This issue affects all Solar 8000M/i Patient Monitors running software version 5.4, 5.5, or 5.6 with the Automatic-View-On-Alarm (AVOA) feature enabled. GE Healthcare will provide a correction at no charge once it is available. We will contact you to arrange for this correction. Please contact Technical Support at 1-800-558-7044 or your local Service Representative. |
| Quantity | 10,211 (7,549 units US, 2,662 units OUS) |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, NS, NO, NE, NH, NH, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI and WY., and the countries of : AUSTRALIA, CANADA, AUSTRIA, BANGLADESH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies, May 11, 2007 |