Reported Mar 20, 2013 · Terminated
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in…
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 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
- Lot codes and dates
- SERIAL NUMBER
592043BU4592676BU1593459BU1593465BU8592458BU4592673BU8592682BU9593059BU9593051BU6593475BU7593476BU5592049BU1593468BU2593054BU0592047BU5592042BU6592046BU7592459BU2593048BU2593056BU5593049BU0593063BU1593062BU3593464BU1594762BU7593473BU2592451BU9593460BU9597954BU7592456BU8592674BU6593052BU4593058BU1590867BU8592050BU9593064BU9592460BU0592457BU6592680BU3592455BU0593462BU5592678BU7594763BU5593055BU7592675BU3592452BU7593463BU3594385BU7
- SERIAL NUMBER
- Amount recalled
- 48
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
Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
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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