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Merge Healthcare Recalls
95 recalls on record · October 22, 2014 to August 12, 2026 · Medical Devices
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 6, 2016Medical DevicesFDA
Merge Healthcare, Inc. recalls Merge Cardio with software version 10.1 LA.
Hazard: 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.
January 6, 2016Medical DevicesFDA
Merge Healthcare, Inc. recalls Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, an
Hazard: 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.
August 12, 2015Medical DevicesFDA
Merge Healthcare, Inc. recalls 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.
Hazard: 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.
November 5, 2014Medical DevicesFDA
Merge Healthcare, Inc. recalls Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the H
Hazard: 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 clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.
October 22, 2014Medical DevicesFDA
Merge Healthcare, Inc. recalls eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communicat
Hazard: 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 incorrect study.