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.
All Recalls
95,018 total recalls in our database
S5-2 Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
3D6-2 Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
C9-4v Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
S3-1 Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
S8-3t Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
D5cwc Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Transducer C10-3v Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
X11-4t Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
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.
L12-3 Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
🏥 Medical Devices Class I - Dangerous
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
🏥 Medical Devices Class I - Dangerous
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.
Mini Multi TEE Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
S4-1 Transducer Probe
Philips Ultrasound
🏥 Medical Devices Class I - Dangerous
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
🏥 Medical Devices Class I - Dangerous
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.
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
American Contract Systems
🏥 Medical Devices Class I - Dangerous
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.