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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 2100 IQ

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 Class 2 Device Recall Innova 2100 IQsee related information
Date Initiated by FirmApril 16, 2009
Date PostedNovember 09, 2009
Recall Status1 Terminated 3 on December 03, 2015
Recall NumberZ-0136-2010
Recall Event ID 52056
510(K)NumberK050489 K052157 K052412 K061163 
Product Classification Cardiovascular Imaging System - Product Code IZI
ProductGE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular 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:  850060731 853060205 82416020006 82416090003 82416120015 82416120016 82416210014 83016022101218 83016842101519 0002780363 00052VAS04  00052VAS05  00060VAS03  010120RX44 082416030012 082416130029 083016002001498 083016802101749 083016822101709 083016862101268 0910064010 110019RX13  1299563 17005VAS01  304526INNOVA  318449INNOVA3  407321INCL2  410368INNOVA1  503561CL1  503561CL4  526354XR13 573815BCR3  603882CATH1  609757IN2100  706774HT4 717217INN21 717544GECATH2  732776CATH4 732923INN 816347SLE2100 816861KCVAI2 816861KCVAI2  818INNOVAHMS1  828315FEP  910343NHIN3  A5152993 A5330714 B5483438 BG4033VA01 C5123626  GOLD010016 HR4106VA01 HR4107VA01 HU1173VA03 LV4000VA04 M4183841 M4484974 RO1180VA01 RU3301VA01 YV0562 
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
ActionConsignees 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 Commerce60
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = IZI
510(K)s with Product Code = IZI
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