Potential leakage of conductivity sensors of the Dialog Dialysis machines.
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Diagnostic Equipment
🏥 Medical Devices • 6,554 recalls
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
Siemens Medical Solutions USA
Class I - Dangerous
The docking station top cover of the removable patient table may contain a magnetic metal plate. When docking/undocking the table, the magnetic top cover may become attracted to the magnet.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Siemens Medical Solutions USA
Class I - Dangerous
While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Doppler gate or cursor, the M-mode cursor, the 2D field of view, or the RES region of interest with the trackball.
Potential leakage of conductivity sensors of the Dialog Dialysis machines.
Class I - Dangerous
The instructional insert for the In Touch Control Solution for use with the In Touch meter and In Touch strips as a quality control check did not contain the limitation of sensor accuracy: (1) with the use of acetaminophen (Tylenol) (2) with the use of Ascorbic Acid (vitamin C) supplementation (3) in the presence of uric acid
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
CareFusion 303
Class I - Dangerous
The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards.
Class I - Dangerous
Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
Becton, Dickinson and Company, BD Biosciences
Class I - Dangerous
One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.
Class I - Dangerous
Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various conditions.
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.
Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error message causes the system to lock up, which requires a reboot to recover system operation.
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
Class I - Dangerous
The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Philips and Neusoft Medical Systems Co.
Class I - Dangerous
The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Hardy Diagnostics
Class I - Dangerous
Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
Roche Molecular Systems
Class I - Dangerous
The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.