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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 IQ see related information
Date Posted November 09, 2009
Recall Status1 Terminated on December 03, 2015
Recall Number Z-0136-2010
Recall Event ID 52056
510(K)Number K052412  K050489  K061163  K052157 
Product Classification Cardiovascular Imaging System - Product Code IZI
Product GE 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
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 60
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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