Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
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Diagnostic Equipment
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A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Class I - Dangerous
A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's sS/Si, Core, and ComboMap systems. This limitation may impact the calculation of Fraction Flow Reserve (FFR) within the Volcano System when the system is connected to the Xper Flex Cardia system via its aortic pressure auxiliary output.
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.
Siemens Healthcare Diagnostics
Class I - Dangerous
Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent delivery. This may lead to unflagged, unexpected low results and results flagged with assay errors.
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
Roche Diagnostics Operations
Class I - Dangerous
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
Roche Diagnostics Operations
Class I - Dangerous
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine.
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
Siemens Healthcare Diagnostics
Class I - Dangerous
D50 and D51 diagnostic error codes are not functional.
Class I - Dangerous
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Siemens Medical Solutions USA
Class I - Dangerous
During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.