| Class 2 Device Recall GE Innova | |
Date Initiated by Firm | May 19, 2008 |
Date Posted | September 30, 2008 |
Recall Status1 |
Terminated 3 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
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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
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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 2 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = MQB 510(K)s with Product Code = MQB
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