Amicas Pacs, Version 6.0

2 recalls, same reason

• Terminated Z-2601-2017 FDA Class II ·initiated 24 May 2017
• Terminated Z-1431-2017 FDA Class II ·initiated 4 Apr 2016

Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.

• Terminated Z-2590-2017 FDA Class II ·initiated 8 May 2017

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

• Terminated Z-2591-2017 FDA Class II ·initiated 8 May 2017

When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.

• Terminated Z-1176-2017 FDA Class II ·initiated 4 Apr 2016

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

• Terminated Z-0599-2017 FDA Class II ·initiated 28 Mar 2016

The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.

• Terminated Z-0726-2017 FDA Class II ·initiated 28 Mar 2016

Cut lines on the image may present horizontally rather than vertically.

• Terminated Z-2363-2016 FDA Class II ·initiated 5 Feb 2016

When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.

2 recalls, same reason

• Terminated Z-2532-2016 FDA Class II ·initiated 30 Jan 2016
• Terminated Z-2531-2016 FDA Class II ·initiated 30 Jan 2016

Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.

• Terminated Z-2301-2016 FDA Class II ·initiated 30 Jan 2016

Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.

• Terminated Z-2303-2016 FDA Class II ·initiated 30 Jan 2016

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

• Terminated Z-2379-2016 FDA Class II ·initiated 30 Jan 2016

The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.