Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 433–444 of 588 recalls
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories.…
This device does not indicate for use in patients with respiratory failure.
This device does not indicate for use in patients with respiratory failure.
This device does not indicate for use in patients with respiratory failure.
Out of specification stability test result for the Caphosol B solution from process validation lots
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1.…
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded.…
Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.
With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound…