Medical device recalls
Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module
Philips Tempus Pro Patient Monitor measures ICP and BDR but these measurements are unvalidated, potentially leading to incorrect clinical decisions.
Integra LifeSciences Codman Microsensor and CereLink ICP Sensor Basic Kits
The Codman Microsensor Basic Kit may have corrosion stains on its included needle.
2 products
Securitas Arial 900 MHz Call Stations
Arial 900 MHz Call Stations may fail to transmit a low battery alert before battery failure.
2 productsMedline Hudson RCI Medium Concentration Oxygen Masks
Medline Hudson RCI Medium Concentration Oxygen Masks can have tubing disconnect, delaying patient care and causing shortness of breath.
IMRIS HFD100 Head Fixation Device
The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.
Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems
Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.
2 products
Meridian Bioscience Revogene C. Difficile Assay
The Revogene C. difficile assay may show a decline in performance over time, leading to false-negative results.
Abbott FreeStyle Libre 3 and FreeStyle Libre 3 Plus Sensors
A manufacturing issue may cause carbon build up in the sensor, leading to incorrect low glucose results.
4 products