Class 2 Device Recall Innova 21211Q/31311Q Biplane Cardiovascular Imaging System.

• Date Initiated by Firm: October 14, 2009
• Date Posted: December 16, 2009
• Recall Status: Terminated on February 04, 2012
• Recall Number: Z-0540-2010
• Recall Event ID: 53596
• 510(K)Number: K060259
• Product Classification: Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
• Product: GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. ; ; Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.
• Code Information: Serial Numbers: 567819BU8 553647BU9 572635BU1 554557BU9 577013BU6 553645BU3 554559BU5 554554BU6 570810BU2 575321BU5 561974BU7 561975BU4 552392BU3 576688BU6 0CLINIC-6 566788BU6 568141BU6 576766BU0 549882BU9 561354BU2 559228BU2 569784BU2 559230BU8 559229BU0 559232BU4 558488BU3 560201BU6 553915BU0 567597BU0 570811BU0 555791BU3 555795BU4 558485BU9 561968BU9 561973BU9 549588BU2 554561BU1 558484BU2 574676BU3 560203BU2 555794BU7 556324BU2 558482BU6 565971BU9 560199BU2 560200BU8 554555BU3 575318BU1 576574BU8 00CLINIC3 556326BU7 556328BU3 555793BU9 555792BU1 558483BU4 561971BU3 558481BU8 553916BU8 570809BU4 566407BU3 567820BU6 573589BU9 553216BU3 559231BU6 553917BU6 561970BU5 561969BU7 577012BU8 561753BU5 551152BU2 549881BU1 556327BU5 00CLINIC4 CLINICAL2 554562BU9 558489BU1 553646BU1 550100BU2 573164BU1 574334BU9 554563BU7 556322BU6 561355BU9 561356BU7 569351BU0 578479BU8 554556BU1 560202BU4 554560BU3 570231BU1 551164BU7 558486BU7 556329BU1 556331BU7 558487BU5 568140BU8 566406BU5 578416BU0 558490BU9 554558BU7 556323BU4 561353BU4 576361BU0 561972BU1 552393BU1 566180BU6 561967BU1 569498BU9 556330BU9 CLINICAL 1 570095BU0 561754BU3 553918BU4 and 556325BU9.
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-544-3894
• Manufacturer Reason for Recall: GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no in
• FDA Determined Cause: Employee error
• Action: GE Healthcare issued an "Urgent Medical Device Correction" notice dated October 14, 2009. The letter was addressed to Hospital Administrators/Risk mangers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact GE Healthcare Systems at 1-800-437-1171, option 4 (U.S.) or contact your local GE Healthcare Service Representative.
• Quantity in Commerce: 114
• Distribution: Worldwide Distribution -- Including the UNITED STATES, YEMEN, UNITED KINGDOM, TAIWAN, SINGAPORE, RUSSIA, ROMANIA, MALAYSIA, LYB IA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, GERMANY, FRANCE, EGYPT, CHILE , CANADA and BAHRAIN.
• 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 = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC