Vericis Cardiovascular Image and Information System, Model 4.0

4 recalls, same reason

• Ongoing Z-1398-2025 FDA Class II ·initiated 19 Feb 2025
• Ongoing Z-1401-2025 FDA Class II ·initiated 19 Feb 2025
• Ongoing Z-1399-2025 FDA Class II ·initiated 19 Feb 2025
• Ongoing Z-1400-2025 FDA Class II ·initiated 19 Feb 2025

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

• Terminated Z-2403-2020 FDA Class II ·initiated 8 May 2020

An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.

• Terminated Z-2123-2017 FDA Class II ·initiated 13 Apr 2016

Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.

• Terminated Z-1403-2017 FDA Class II ·initiated 4 Apr 2016

When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure.

• Terminated Z-1486-2017 FDA Class II ·initiated 4 Apr 2016

Cardio study list does not show STAT studies without refreshing.

• Terminated Z-1415-2017 FDA Class II ·initiated 4 Apr 2016

A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt.

• Terminated Z-1046-2017 FDA Class II ·initiated 28 Mar 2016

If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.

• Terminated Z-0729-2017 FDA Class II ·initiated 28 Mar 2016

If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).

• Terminated Z-2709-2016 FDA Class II ·initiated 9 Feb 2016

A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

• Terminated Z-2865-2016 FDA Class II ·initiated 30 Jan 2016

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

• Terminated Z-0555-2016 FDA Class II ·initiated 26 Oct 2015

The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

• Terminated Z-0730-2017 FDA Class II ·initiated 1 Oct 2015

Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.

• Terminated Z-1496-2017 FDA Class II ·initiated 22 Sep 2015

For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.

• Terminated Z-1517-2017 FDA Class II ·initiated 22 Sep 2015

Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.