• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Innova 3100 / 3100 IQ

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Innova 3100 / 3100 IQsee related information
Date Initiated by FirmApril 16, 2009
Date PostedNovember 09, 2009
Recall Status1 Terminated 3 on December 03, 2015
Recall NumberZ-0135-2010
Recall Event ID 52056
510(K)NumberK031637 K042053 K052157 K052412 K061163 
Product Classification Cardiovascular Imaging System - Product Code MQB
ProductGE 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 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 Commerce78
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 = MQB
510(K)s with Product Code = MQB
510(K)s with Product Code = MQB
510(K)s with Product Code = MQB
-
-