Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 181–192 of 426 recalls
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Potential for microbial contamination.
Fungal contamination of affected lot with Parengyodontium album.
Emphasizing instructions for LVP duration programming located in the IFU.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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.