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GE Medical Systems, LLC recalls GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Recalled June 1, 2016 · FDA recall Z-1706-2016 · GE Medical Systems
Hazard
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. · FDA Class II
Units
54
Sold at
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 ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Description
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.
Product
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Manufacturer(s)
GE Medical Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →