Reported Sep 19, 2012 · Terminated
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ)…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems
- K060259The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications
- K061163
For Innova 2121IQInnova 3131IQInnova 4100Innova 4100IQInnova 3100Innova 3100IQInnova 2100IQ
- devices with Innova IVUS optionThe Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications
- Innova IVUS OptionThe Innova IVUS software option simplifies the clinical workflow associated with
- the use of Volcano IVUS products by(1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system
- K091658The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications
- Lot codes and dates
- System ID (As required)NA
83 of 83 codes
910162015AZ4001VA01BH1000VA01BY4033VA01BY4020VA02BG4549VA01BG4009VA01416480INNOVA2HSRINNOVA182416070010824161500078241621002282416040046CS1006VA05EG1000VA01M4198064N4192939M4166990M4212443HC1819XR10HC5284XR39542120XR02HC5284XR3883016862100448835160028IQ1165VA02IE1100VA03A5632421A5102694A5379605A5320145B5114298A5360408YV0370YV0365YV0364YV0166YV0369YV0473YV0480YV0478YV0475YV0362YV0510YV0474YV0481YV0367YV0477YV0388YV0466YV0500YV0463YV0476YV0464YV0462YV0400YV0366YV0501YV0520YV0363
BMANGIO 936539CL4 936WH2121 214590EP2121 BMEP 713794LAB8 832355LAB4 713794LAB11 281440BP31 210617VACATH1 MCDEP131 of 131 codes
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
801532LCA540776LGVAS2276258INV3131434654CATH2121253627INNOVA5206598UWBP253403CL4509474BIP509473RM141464921214144473131ECXV1402B304526INNOVABPYE1002VA01
- System ID (As required)
- Amount recalled
- 240 (133 US and 107 OUS)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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