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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Discovery IGS 730 & Discovery IGS 740

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  Class 2 Device Recall GE Healthcare, Discovery IGS 730 & Discovery IGS 740 see related information
Date Initiated by Firm December 10, 2014
Date Posted January 14, 2015
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-0966-2015
Recall Event ID 70073
510(K)Number K113403  K133278  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product 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 generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

Code Information  Mfg Lot or Serial # System ID 0000013C2A0001 203694IGS730 0000011C2A0005 610954OR1 0000014A2A0009 718283D740 0000014A2A0007 SO4208228 0000014A2A0016 SO4242294 0000014A2A0004 206VMDISCOVERY1 Not available 330375HOR 0000014A2A0006 190020RX26 Not available 190059RX30 Not available SO4165355 Not available 82416120043 Not available 82416040061 00000011C2A003 A4185526 0000012C2A0002 M4160476 0000014A2A0008 S41600101 00000612802BU9 M54866AG1 Not available M40480222 Not available HC4348XR11 0000014A2A0001 YV2000 Not available XR649425BU6 Not available SO4239583 Not available AE1477RX04 0000013A2A0003 00169VAS01 0000013A2A0002 10692VAS01 
Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.
FDA Determined
Cause 2		 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 in Commerce 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.
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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