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U.S. Department of Health and Human Services

Class 2 Device Recall Innova 3100 / 3100 IQ

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 Class 2 Device Recall Innova 3100 / 3100 IQ see related information
Date Posted November 09, 2009
Recall Status1 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
262-544-3894
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 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 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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