Device Recall RadSuite

  • Modèle / numéro de série
    Versions: 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E, SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, and 5.35.4 HF0513
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to AL, AZ, CA, IL, MD, MA, MI, MO, NV, NJ, NC, OH, PA, TN, and VA. Government distribution was made to OK. There was no foreign/military distribution.
  • Description du dispositif
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
  • 1 Event

Fabricant

4 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E,  5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560,  5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to the states of : MN, WI, IL, PA, AL, MO, MT, AZ, CA, OH, FL, SC, MI, TN, CO, NV, IN, NY, MD, AR, KS, NY, IN, IA, TX, OK, NC, WA and DC.
  • Description du dispositif
    RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, || 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 5.35.4 HF0555, 5.35.4 HF0555.1, 5.35.4 HF0555.2, 5.35.4 HF0555.3, 5.35.4 HF0560, || 5.35.4 Powerscribe Validation, 5.35.5, 5.35.5 From CCS, 5.35.5.1, 8.30.0, 8.30.1, 8.30.3, 8.30.3.1, 8.30.4, 8.30.5, 8.30.6, 8.30.6.1, 8.30.6.2, 8.30.6.3, 8.30.7, 8.30.7.1, 8.30.7.2, 8.30.7.3, 8.30.7.3-Hopkins, 8.30.7.4, 8.30.7.5, 8.30.7.5.b, 8.30.7.6, 8.30.7.7, 8.30.7.8.
  • Manufacturer
  • Modèle / numéro de série
    This potential patient safety issue is only present in the following versions when a reverse workflow is used: 2004-R6.x, 5.10.x, 5.20, 5.25, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30.X SB0381E, 5.35.1, 5.35.1 HF0487E, 5.35.1 HF0489E, 5.35.2, 5.35.3, 5.35.4, 5.35.4 HF0513, 5.35.4 HF0518, 5.35.4 HF0528, 5.35.4 HF0531, 5.35.4 HF0535, 5.35.4 HF0546, 8.30.0.  NOTE: The standard workflow is not impacted.  .
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
  • Description du dispositif
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
  • Manufacturer
  • Modèle / numéro de série
    Versions V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to: CO and OK.
  • Description du dispositif
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. || RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
  • Manufacturer
  • Modèle / numéro de série
    RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, CA, FL,IN, MI, MO, NY, PA, TN, and WI.
  • Description du dispositif
    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. || Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data || The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: || ¿ Radiologists can view, annotate, and tag studies as diagnostically Read. || ¿ Referring physicians can view patient images and radiologists annotations. || ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.
  • Manufacturer