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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging System

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  Class 2 Device Recall GE Healthcare Discovery IGS 730 Cardiovascular XRay Imaging System see related information
Date Initiated by Firm June 19, 2013
Date Posted September 18, 2013
Recall Status1 Terminated 3 on October 25, 2013
Recall Number Z-2253-2013
Recall Event ID 66168
510(K)Number K113403  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System.

The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Code Information Mfg Lot or Serial # 00000611882BU2 00000612803BU7 00000613979BU4 00000620447BU3                                                    
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has recently become aware of a potential safety issue with respect to Discovery IGS 730 Imaging Systems. A patient data management error may prevent the Discovery IGS 730 Imaging System from booting on start-up or re-booting during procedure. The boot issue may occur when a large amount of patient data remains in the browser and is not deleted. The inability to boot the system ma
FDA Determined
Cause 2		 Software design
Action The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 19, 2013 to its Consignees/customers. The letter described the Safety Issue, Safely Instructions, Affected Product Detail, Product Correction and Contact Information. The consignees were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected systems at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please call : United States: 800 437 1171. For other countries, please contact your local GE Healthcare Service Representative.
Quantity in Commerce 4 (2 US, 2 OUS)
Distribution Worldwide distribution: US (nationwide) including states of : PA and TN; countries of: FRANCE and SINGAPORE.
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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