Merge Healthcare recalls
Merge Healthcare appears in 96 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software
FDA Device · Class II · 2017-02-22 · Merge Healthcare
Reason: Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. - Merge RadSuite software
FDA Device · Class II · 2017-02-15 · Merge Healthcare
Reason: 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. - Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Im…
FDA Device · Class II · 2017-02-15 · Merge Healthcare
Reason: 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. - Merge PACS software
FDA Device · Class II · 2017-02-15 · Merge Healthcare
Reason: Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. - Merge Hemo software
FDA Device · Class II · 2017-02-01 · Merge Healthcare
Reason: 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. - Merge Cardio software
FDA Device · Class II · 2017-01-25 · Merge Healthcare
Reason: 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 pr… - Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Ima…
FDA Device · Class II · 2017-01-18 · Merge Healthcare
Reason: This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. - DR Systems Unity PACS software, now known as Merge Unity PACS software
FDA Device · Class II · 2017-01-11 · Merge Healthcare
Reason: The software fails to associate to the correct MG image if there are two images for the same view. - Merge OrthoCase software
FDA Device · Class II · 2016-12-28 · Merge Healthcare
Reason: 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. - Merge Cardio software
FDA Device · Class II · 2016-12-21 · Merge Healthcare
Reason: 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 numbe… - Merge Cardio software
FDA Device · Class II · 2016-12-21 · Merge Healthcare
Reason: 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. - Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. e…
FDA Device · Class II · 2016-12-14 · Merge Healthcare
Reason: 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 calibra… - Merge PACS software
FDA Device · Class II · 2016-12-14 · Merge Healthcare
Reason: Cut lines on the image may present horizontally rather than vertically. - Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate conn…
FDA Device · Class II · 2016-12-07 · Merge Healthcare
Reason: 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 softwa… - Merge Hemo software
FDA Device · Class II · 2016-12-07 · Merge Healthcare
Reason: The application may crash during the cath lab procedure. - Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31
FDA Device · Class II · 2016-11-30 · Merge Healthcare
Reason: 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-ra… - iConnect Access software
FDA Device · Class II · 2016-11-23 · Merge Healthcare
Reason: Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. - Merge LIS software
FDA Device · Class II · 2016-11-23 · Merge Healthcare
Reason: There is a potential for duplicate container numbers to be created for patients. - Merge PACS software
FDA Device · Class II · 2016-11-23 · Merge Healthcare
Reason: 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. - Fusion Workstation
FDA Device · Class II · 2016-10-26 · Merge Healthcare
Reason: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. - CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting…
FDA Device · Class II · 2016-10-26 · Merge Healthcare
Reason: Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up. - CADstream software
FDA Device · Class II · 2016-10-26 · Merge Healthcare
Reason: 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 fol… - Merge Cardio software
FDA Device · Class II · 2016-09-28 · Merge Healthcare
Reason: Patient information in the header is only found on the first page of the report and not on the subsequent pages. - CADstream software
FDA Device · Class II · 2016-09-28 · Merge Healthcare
Reason: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application. - RadSuite software
FDA Device · Class II · 2016-09-21 · Merge Healthcare
Reason: Multiple studies were missing at a customer location that never made it to the archive before watermarking - Merge RadSuite software
FDA Device · Class II · 2016-09-14 · Merge Healthcare
Reason: 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 p… - RadSuite software
FDA Device · Class II · 2016-09-07 · Merge Healthcare
Reason: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. - iConnect Enterprise Archive
FDA Device · Class II · 2016-09-07 · Merge Healthcare
Reason: Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. - Merge Cardio software
FDA Device · Class II · 2016-09-07 · Merge Healthcare
Reason: 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). - RadSuite software
FDA Device · Class II · 2016-08-31 · Merge Healthcare
Reason: 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. - iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various t…
FDA Device · Class II · 2016-08-24 · Merge Healthcare
Reason: 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 th… - Merge Unity Z3D software
FDA Device · Class II · 2016-08-24 · Merge Healthcare
Reason: The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. - iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various t…
FDA Device · Class II · 2016-08-24 · Merge Healthcare
Reason: 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 th… - Merge PACS software
FDA Device · Class II · 2016-08-17 · Merge Healthcare
Reason: 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. - Merge PACS software
FDA Device · Class II · 2016-08-17 · Merge Healthcare
Reason: The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. - Merge PACS software
FDA Device · Class II · 2016-08-10 · Merge Healthcare
Reason: 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. - Merge PACS software
FDA Device · Class II · 2016-08-10 · Merge Healthcare
Reason: Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. - Merge HEMO software
FDA Device · Class II · 2016-08-10 · Merge Healthcare
Reason: 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 - Merge OfficePACS software
FDA Device · Class II · 2016-07-20 · Merge Healthcare
Reason: Potential data loss occurs as a result of product archiving not working properly. - Merge OfficePACS software
FDA Device · Class II · 2016-07-20 · Merge Healthcare
Reason: Potential data loss occurs as a result of the software archiving not working properly. - RadSuite, a picture archive and communications system
FDA Device · Class II · 2016-02-17 · Merge Healthcare
Reason: Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite. - Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic…
FDA Device · Class II · 2016-01-06 · Merge Healthcare
Reason: 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. - Merge Cardio with software version 10.1 LA
FDA Device · Class II · 2016-01-06 · Merge Healthcare
Reason: 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. - Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module
FDA Device · Class II · 2015-08-12 · Merge Healthcare
Reason: A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab. - Merge Healthcare, Merge Hemo Programmable diagnostic computer
FDA Device · Class II · 2014-11-05 · Merge Healthcare
Reason: It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger cli… - eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System)
FDA Device · Class II · 2014-10-22 · Merge Healthcare
Reason: There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an i…