Class 2 Device Recall GE Innova

• Date Initiated by Firm: May 19, 2008
• Date Posted: September 30, 2008
• Recall Status: Terminated on June 30, 2016
• Recall Number: Z-1521-2008
• Recall Event ID: 49538
• 510(K)Number: K031637 K042053
• Product Classification: Solid State X-Ray Imager - Product Code MQB
• Product: GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System)
• Code Information: Systems Id: 8613100, 0910163013, 4103323100, 4103623100, 5034353100, 7083333100, 7278253100, 8019643100, 82416040010, 082416040016, 082416040017, 082416050002, 082416070004, 082416100008, 82416120005, 082416120006, 082416130013, 0002581738X, 06074VAS01, 201541LAB2, 214324INNOVA2, 24516572980IN, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 314768SMCL3, 318448INNOVA2, 318449INNOVA2, 409899LAB3, 413447CATH, 413540IN1, 417269SCLD, 502587LAB4, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573815BCR1, 600130VA01, 601553CL3, 602239LAB4, 602239LAB6, 602266LAB2, 603778ECL1, 608524NOVA, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 702616INNOVA, 7028803100A, 713794LAB7, 713794LAB9, 714966INNOVA, 718283INNOVA3, 724773C1, 731422CV1, 732294INOV, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 808547QCV2A, 812238LIB1, 812283IN31, 812482INNOVA, 815599FHN3100, 817433HSW3100, 83INNOVA1188379, 850678IN3100, 904202CATH3, 908522LAB1, 928779INNOVA1, 936266CL1, 956389INN31, 956698INN31, 956994INN1, 956994INN2, 973971LAB3, A5108239, A5203215, BPINNOVA2, BPINNOVA3R, DK1066VA01, FHORLCL1, H1420VAS04, HC1536XR04, IQ1083VA01, IR1747VA01, LB1160XR07, LV4012VA01, M2848425, M2970614, PL1622VA01, RU1156VA01, RU1482VA02, RU1550VA01, RU2457VA01, TT-2586581-CO, YV0022, YV0026, YV0036.
• Recalling Firm/ Manufacturer: Datex - Ohmeda, Inc; Po Box 7550; Madison WI 53707
• For Additional Information Contact: 608-221-1551
• Manufacturer Reason for Recall: GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).
• FDA Determined Cause: Software design
• Action: An Urgent Medical Device Correction letter, dated June 2008 was sent to customers The letter described the issue, affected products and provided short term user recommendations. GE developed a new software release that corrects this condition and will launch the corrective action to upgrade all affected systems.
• Quantity in Commerce: 107
• Distribution: Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.
• 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; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, INC.