Merge Healthcare Recalls

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

Hazard: A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing.

Hazard: The application may crash during the cath lab procedure.

Hazard: Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

Hazard: 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).

Hazard: Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

Hazard: 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.

Hazard: There is a potential for duplicate container numbers to be created for patients.

Hazard: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.

Hazard: The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up.

Hazard: Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.

Hazard: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

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

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

Hazard: 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.

Hazard: 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).

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

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

Hazard: 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.

Hazard: The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

Hazard: 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.

Hazard: 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.

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

Hazard: 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.

Hazard: The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

Hazard: 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.

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

Hazard: Potential data loss occurs as a result of product archiving not working properly.

Hazard: Potential data loss occurs as a result of the software archiving not working properly.

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