Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 157–168 of 262 recalls
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV.…
The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the h…
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports.
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.