Class 2 Device Recall Innova 3100 / 3100 IQ

• Date Initiated by Firm: April 16, 2009
• Date Posted: November 09, 2009
• Recall Status: Terminated on December 03, 2015
• Recall Number: Z-0135-2010
• Recall Event ID: 52056
• 510(K)Number: K031637 K042053 K052412 K061163 K052157
• Product Classification: Cardiovascular Imaging System - Product Code MQB
• Product: GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
• Code Information: SYSTEM ID: 65049331 850060732 2538483100 4082593100 7133933100 9284533100 82416060004 0002728403 01224VAS04 082416040025 082416100008 082416120017 082416230005 202782LABB 214324INNOVA2 27305ANGI1 303629CL4 303788CL2 318254CL 325428CATH1 361857CATH1 361980INNOVA2 478274CTH1 479441CV1 4959INV31 503561CL3 512901NI3100 563421CATHLAB8 573AMC3100 600123VA02 619482INNOVA1 650369SV3 704355RM2 706774HT8 717270INNOVA31 727942CATH 732776CATH6 770HMCCL2 787844INNOVACL 803256LAB2 808485INNOVA 814231C1 815226INN2 864512CL1 864512CL2 865481CCL2 951788INNOVA2 A51273120 BPINNOVA4 BPINNOVA5 BY4067VA02 BY4069VA01 FPG30528 HU1042VA01 IL1098VA01 NPV15952 PL1008VA02 RU1295VA03 RU1295VA04 RU1453VA01 RU1618VA01 RU1999VA01 RU2076VA02 RU2741VA03 RU2747VA01 RU3260VA01 RU3290VA01 RU3304VA01 RU3317VA01 RU3328VA01 UA4230VA01 XF0158 YV0044 YV0171 YV0175 YV0180 YV0700 Z001RX07
• 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: Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra
• FDA Determined Cause: Device Design
• Action: Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
• Quantity in Commerce: 78
• Distribution: Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
• 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 HEALTHCARE; 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.; 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC