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All product recalls associated with Deerfield Imaging, Inc..
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Feb 2022
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown.
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible