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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Discovery IGS 740.

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  Class 2 Device Recall GE Healthcare, Discovery IGS 740. see related information
Date Initiated by Firm April 15, 2016
Date Posted May 23, 2016
Recall Status1 Terminated 3 on November 22, 2016
Recall Number Z-1707-2016
Recall Event ID 73968
510(K)Number K133278  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Code Information Mfg Lot or Serial # System ID Mfg Lot or Serial # System ID 664365BU4 804828CATH4 669085BU3 573815D730 668484BU9 714FVDISC 672437BU1 775770CATHLAB3 0000HXF3001331 801714DIS730 00000632172BU3 203694IGS730 00000633128BU4 309624FT6 00000633831BU3 619532DISCOVERY 00000630288BU9 303426IR 0000HXF3001333 949250DISC730 00000637023BU3 214345IGS730 0000HXE9001300 650723SC1 00000646169BU3 330375HOR 00000638611BU4 414649DIS1 00000646917BU5 720854IGS730 00000614688BU0 610954OR1 00000622054BU5 423778DISC 646007BU5 206VMDISCOVERY1 00000637724BU6 281BAYIGS730 Not Avaialble GON4345699 Not Avaialble GON4110095 Not Avaialble DZ1104VA03 00000661681BU7 030078RX05 00000651337BU8 190059RX30 00000659126BU7 210060RX14 0000HXE9001292 613722D730 00000650197BU7 082416040061 00000653093BU5 082416040069 00000668482BU3 082416040074 Not Avaialble 082416060019 00000653092BU7 082416100080 00000651999BU5 082416120043 Not Avaialble 082416200019 00000618688BU6 M54866AG1 00000614687BU2 A4185526 0000013A2A0001 M40480222 00000623224BU3 M4160476 00000663234BU3 M94838145 00000646918BU3 S41600101 00000650095BU3 HC4348XR11 00000671395BU2 HC4348XR14 00000660146BU2 HU1205VA03 00000627794BU1 IE1147VA01 00000672728BU3 B5120737 00000642198BU6 YV2000 BAPFI0033-0011 XV649425BU6 00000653091BU9 XVE14287001 Not Avaialble SA2454VA01 00000615500BU6 0847160010 0000014A2A0010 AE1477VA01 Not Avaialble GON4316421 00000642197BU8 10692VAS01 00000638812BU8 00169VAS01 Not Avaialble 00584VAS06 
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact GE Healthcare Service
800-437-1171
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 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 in Commerce 25
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 ARABIA, SINGAPORE, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = GE MEDICAL SYSTEMS SCS
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