Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 48 recalls
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Unapproved design changes to the products outside of the 510(k) clearance.
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO mea…
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.…
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.…
Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power management boards, if the AC mains power is unplugged or in the event of an AC mains power failure.…