Recall archive
353 recalls · page 9 of 15
Reported Mar 29, 2017
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2017
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — 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.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 15, 2017
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2017
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — The software is not adding the correct tomo image.
FDA (openFDA device enforcement)
Reported Mar 1, 2017
Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product details — Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical…
FDA (openFDA device enforcement)
Reported Feb 22, 2017
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand — Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI. In the event of a RF component failure, typically…
FDA (openFDA device enforcement)
Reported Feb 22, 2017
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.
FDA (openFDA device enforcement)
Reported Feb 15, 2017
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2017
OEC 9800. MDL Numbers: D222250, D141598
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
Matched: Brand · Reason for recall — GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2017
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — 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.
FDA (openFDA device enforcement)
Reported Jan 25, 2017
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Infant Warmer System (IWS)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS).…
FDA (openFDA device enforcement)
Reported Jan 18, 2017
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE OEC Medical Systems, Inc.
Matched: Brand · Reason for recall — GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2017
Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user.
FDA (openFDA device enforcement)
Reported Jan 11, 2017
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — The software fails to associate to the correct MG image if there are two images for the same view.
FDA (openFDA device enforcement)
Reported Jan 4, 2017
Innova 2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX,…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in…
FDA (openFDA device enforcement)
Reported Dec 21, 2016
GE Healthcare, Avance, Avance CS2, Amingo.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue where certain Avance CS2, Avance and Amingo anesthesia devices can transition to a System…
FDA (openFDA device enforcement)
Reported Dec 21, 2016
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 14, 2016
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 7, 2016
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 30, 2016
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in…
FDA (openFDA device enforcement)
Reported Nov 23, 2016
Merge LIS software.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — There is a potential for duplicate container numbers to be created for patients.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2016
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient…
2 more products in this recall
FDA (openFDA device enforcement)
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