Recall Z-1706-2016 ยท OWB Interventional Fluoroscopic X-Ray System
GE Medical Systems, LLC
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
| Date | May 23, 2016 (initiated Apr 15, 2016) |
| Status | Terminated |
| Reason | Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a real-time fluoroscopic Interventional procedure. |
| Root cause | Device Design |
| Action | Consignees were sent on 4/15/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref#12246 dated April 14, 2016. 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. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 54 |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AL, CA, CO, CT, IL, IN, MD, MN, MS, MO, NE,NV,NH, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of ALGERIA, BELGIUM CANADA, CHINA, FRANCE, GERMANY, HUNGARY, IRELAND, ITALY, JAPAN, MEXICO, NETHERLANDS, PERU, SAUDI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113403 | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM GE Medical Systems SCS, Feb 14, 2012 |