Class 2 Device Recall Advantage Workstation

• Date Initiated by Firm: May 01, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on December 11, 2011
• Recall Number: Z-2312-2008
• Recall Event ID: 48738
• 510(K)Number: K041521
• Product Classification: System, image processing, radiological - Product Code LLZ
• Product: Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.
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• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.
• FDA Determined Cause: Software design
• Action: Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.
• Quantity in Commerce: 5,249 (2,104 US/ 3,145 OUS)
• Distribution: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Algeria Argentina Australia Austria Belgium Bosnia Brazil Bulgaria Byelorussian SSR Canada Chile China Columbia Croatia Cyprus Czech Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Guadeloupe Guatemala Guyana Honduras Hungary India Indonesia Iran Ireland Israel Italy Jamaica Japan Korea Kuwait Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macedonia Malaysia Mexico Morocco Netherlands New Zealand Norway Oman Pakistan Panama Paraguay Peru Philippines Poland Portugal Puerto Rico Puerto Rico Romania Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand Trinidad Tunisia Turkey Ukraine United Aran Emirates United Kingdom Uruguay Venezuela Vietnam Yugoslavia
• 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 = LLZ and Original Applicant = GENERAL ELECTRIC MEDICAL SYSTEMS