Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–72 of 2,908 recalls
Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer;…
Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds.…
Recalled lots were manufactured with double the amount of preservative concentration.
The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments.…
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.
GE HealthCare has become aware that the Patient History tab in ViewPoint 6 versions 6.15.3 and 6.15.4 ultrasound software may not include complete patient medical history information.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Potential for incomplete seal on header bag.
Potential for incomplete seal on header bag.
Potential for incomplete seal on header bag.
Potential for incomplete seal on header bag.