Recall Z-0966-2015 ยท OWB Interventional Fluoroscopic X-Ray System
GE Healthcare
GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in gene
| Date | Jan 14, 2015 (initiated Dec 10, 2014) |
| Status | Terminated |
| Reason | Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products. |
| Root cause | Software design |
| Action | Consignees were sent a 12/10/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 12223 dated December 10, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information ( US call 800-437-1171, other countries contact your local GE Healthcare Service Representative). |
| Quantity | 24 ( 7 US, 17 OUS) |
| Distribution | Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |