Merge Healthcare Recalls

Hazard: The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.

Hazard: During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

Hazard: Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

Hazard: An error message can occur resulting in the prior studies being unavailable for viewing.

Hazard: The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.

Hazard: The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease.

Hazard: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.

Hazard: 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.

Hazard: System locks up which may result in potential patient injury or delay in diagnosis or treatment.

Hazard: 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.

Hazard: Cardio study list does not show STAT studies without refreshing.

Hazard: 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.

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

Hazard: In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

Hazard: 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.

Hazard: Reports were missing demographic header information when they were faxed to referring physicians.

Hazard: 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.

Hazard: The software is not adding the correct tomo image.

Hazard: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Hazard: Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

Hazard: 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.

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

Hazard: Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health.

Hazard: There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Hazard: 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.

Hazard: This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.

Hazard: The software fails to associate to the correct MG image if there are two images for the same view.

Hazard: Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.

Hazard: 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.

Hazard: 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).