Evms (Enterprise Visual Medical System Software)

• • Terminated Z-0614-2017 FDA Class II ·initiated 14 Jul 2016

  It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray).

• • Terminated Z-1470-2017 FDA Class II ·initiated 4 Apr 2016 ·on shared 510(k) K053281

  The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment.

• • Terminated Z-2627-2016 FDA Class II ·initiated 31 Jan 2016

  Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport.

• • Terminated Z-2685-2016 FDA Class II ·initiated 30 Jan 2016

  Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.

• • Terminated Z-0794-2016 FDA Class II ·initiated 17 Dec 2015

  Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.

• • Terminated Z-1180-2017 FDA Class II ·initiated 17 Nov 2015

  The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.

• • Terminated Z-2715-2016 FDA Class II ·initiated 9 Apr 2015

  When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient.

• • Terminated Z-2796-2016 FDA Class II ·initiated 6 May 2013

  Multiple studies were missing at a customer location that never made it to the archive before watermarking

• • Terminated Z-1644-2008 FDA Unclassified (pre-2012) ·initiated 1 Jan 2008

  Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K053281 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Heartsuite Hemodynamics 7.10

  Class II

  FDA 510(k) K082421 Active Cleared 17 Dec 2008