🏥 Medical Devices • 6,554 recalls
It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quantities in serum due to acetaminophen overdoese. This could result in a delay in diagnosis and treatment.
Philips North America
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Perfusion tubing pack was packaged with the incorrect cuvette.
Siemens Healthcare Diagnostics
Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
Siemens Healthcare Diagnostics
Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.
Philips Medical Systems Gmbh, DMC
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Philips Medical Systems Gmbh, DMC
When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the unit in case of transformer overheating, was installed incorrectly at production.
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Hitachi Medical Systems America
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.
Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
Roche Diabetes Care
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Roche Diabetes Care
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Cardinal Health 200
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.
Cardinal Health 200
The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range (¿ 0.2¿C for Genius 2 and ¿ 0.3¿C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2¿C for Genius 2 or +0.3¿C for Genius 3.