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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 4100 / 4100 IQ

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  Class 2 Device Recall Innova 4100 / 4100 IQ see related information
Date Initiated by Firm April 16, 2009
Date Posting Updated November 09, 2009
Recall Status1 Terminated 3 on December 03, 2015
Recall Number Z-0137-2010
Recall Event ID 52056
510(K)Number K033244  K023178  K042053  K052412  K061163  K052157  
Product Classification Cardiovascular Imaging System - Product Code IYO
Product GE Healthcare, GE Innova 4100 / 4100 IQ. , ( 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:

80158241, 06014VAS01, 06063VAS01, 082406100018, 0828160011, 205759CL2 , 207662OR4100, 215662INNOVA1 , 216844INNOVA , 228809VASC , 22925941V2 , 309672M4100, 414649DVI, 508383IN4100, 509575YM4100 , 6012884100SUR , 715369INN4100, 718518CVL1 , 801268INNOVA, 812825INNOVA1, 843789SP1 , 865373SP, 865541CCL5 , 904BSSP , 910907WAVAS1 , 9408984100, A56364110, BG4037XR01, HC1819XR09, HC2001XR02, M2030711 , NO1017VA03, NO1064VA04, RU2526VA01, XF0160.
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 2
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 35
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 = IYO and Original Applicant = GE HEALTHCARE
510(K)s with Product Code = IYO and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = IYO and Original Applicant = GE MEDICAL SYSTEMS, LLC
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