🏥 Medical Devices • 15,809 recalls
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
Mevion Medical Systems
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
Mevion Medical Systems
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).
Philips Medical Systems (Cleveland)
The product label does not include the correct current rating.
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instructions for Use (IFU).
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
Merge Healthcare
There is a potential for duplicate container numbers to be created for patients.
Siemens Healthcare Diagnostics
Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Philips Medical Systems (Cleveland)
The product label does not include the correct current rating.
Philips Medical Systems (Cleveland)
The product label does not include the correct current rating.
Philips Medical Systems (Cleveland)
The product label does not include the correct current rating.
Roche Diabetes Care
Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.
Stryker Instruments Div. of Stryker
Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.
Mevion Medical Systems
Recovery of Incorrect Isocenter -operational change
Philips Medical Systems (Cleveland)
The product label does not include the correct current rating.
Philips Medical Systems (Cleveland)
The product label does not include the correct current rating.
Siemens Healthcare Diagnostics
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.