Recall archive
353 recalls · page 10 of 15
Reported Oct 19, 2016
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray…
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 Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the…
FDA (openFDA device enforcement)
Reported Sep 28, 2016
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Patient information in the header is only found on the first page of the report and not on the subsequent pages.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2016
RadSuite 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 — Multiple studies were missing at a customer location that never made it to the archive before watermarking
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare It
Matched: Brand — There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. In an unlikely…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
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 is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could…
FDA (openFDA device enforcement)
Reported Sep 14, 2016
Merge RadSuite software. Radiological image processing system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare It
Matched: Brand — The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto…
FDA (openFDA device enforcement)
Reported Sep 7, 2016
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 31, 2016
RadSuite 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 — 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…
FDA (openFDA device enforcement)
Reported Aug 24, 2016
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare It
Matched: Brand · Product · Product details — While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of…
FDA (openFDA device enforcement)
Reported Aug 24, 2016
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2016
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Studies coming over via telmed were missing patient's DOB, procedure, and referring physician.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2016
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare It
Matched: Brand — A software defect was discovered that causes images to be out of context with clinical information.
FDA (openFDA device enforcement)
Reported Jul 20, 2016
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand · Product · Product details — Potential data loss occurs as a result of the software archiving not working properly.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 13, 2016
GE Healthcare, Discovery MR750w
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 recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore…
FDA (openFDA device enforcement)
Reported Jun 15, 2016
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2016
GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — Potential non-recoverable loss of image acquisition. The affected Discovery systems may experience multiple X-Ray abort errors before or during a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 4, 2016
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in…
FDA (openFDA device enforcement)
Reported Apr 20, 2016
GE Healthcare, Aisys CS2 anesthesia..
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21%…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 16, 2016
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product details · Reason for recall — GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2016
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Reason for recall — GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2016
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merge Healthcare, Inc.
Matched: Brand — Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.
FDA (openFDA device enforcement)
Reported Jan 27, 2016
GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
Matched: Brand · Product · Product details — The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the…
5 more products in this recall
FDA (openFDA device enforcement)
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