X5-1c Transducer Probe
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Medical equipment, implants, and diagnostic devices
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Due to out of the box wobble of the driver.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Philips Ultrasound
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.