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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
Invalid calibrations (out of range high) while using the product.
Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.
Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.
Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.
Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.
The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy.
Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.