Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 133–144 of 371 recalls
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact.…
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Device packaged in incorrect outer box carton.
Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended.…
Removal of affected lot of screws due to labeling error.
Recalled lots were manufactured with double the amount of preservative concentration.
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer.…
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during…
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during…
Potential issue where the IntelliVue monitors did not alarm.