GE Healthcare CARESCAPE Respiratory Module E-sCAiOVE recall — FDA Z-0759-2020
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Complete FDA and NHTSA recall records dated in 2020, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain…
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the…
If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula…
The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile…
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the…
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the…
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the…
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
undeclared milk
Salmon meals may contain undeclared wheat
The firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were subsequently used to manufacture various salad and deli…
Salmon meals may contain undeclared wheat
The firm received a recall notice for hardboiled eggs that were potentially contaminated with Listeria monocytogenes. The eggs were subsequently used to manufacture various salad and deli…
Eggs in RTE bacon and egg packet may contain Listeria Monocytogenes.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.