🏥 Medical Devices • 6,554 recalls
Biosound Esaote
Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.
Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.
Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca
An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering. Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened.
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.
Product is not approved or authorized for distribution in the US.