Medical device recalls
Baxter SIGMA Spectrum Infusion Pump
The SIGMA Spectrum Infusion Pump has defective grease that may cause over-infusion or free-flow.
Mazor Robotics Mazor X Robotic Guidance System
The Mazor X robotic guidance system has software errors that can result in incorrect surgical instrument positioning during spinal surgery.
GE Healthcare Omni Legend PET Scanners
Omni Legend systems may show a streaking artifact in PET scan images.
Thoratec CentriMag Blood Pump and Kits
The CentriMag blood pump may not fit into the motor and may not lock securely, which could lead to stroke, embolism, or death.
Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution
ThinPrep CytoLyt Solution, a buffered cell wash solution, is contaminated with Parengyodontium album.
ICU Medical Plum Duo Infusion System
The Plum Duo Infusion System may fail to produce audible alarms, alerts, or feedback for touchscreen inputs.
Medtronic Abre Venous Self-Expanding Stent System
The Abre Venous Self-Expanding Stent System may have a Nitinol anomaly causing reduced stent diameter and radial force, potentially leading to migration.
Intuitive Surgical da Vinci SP Access Port Kit
The da Vinci SP Access Port Kit may develop cracks, potentially causing a sterility breach.
C-RAD Catalyst+ Patient Positioning Devices
The Catalyst and Catalyst+ patient positioning device may show a patient as correctly positioned even when the isocenter is outside tolerance.
Philips Azurion Systems
Philips Azurion Systems R3.0 have software issues that may cause loss of X-ray and other problems.
Philips Azurion Systems
Philips Azurion Systems have software issues that may cause system restarts and positional errors.
Medline Medical Procedure Convenience Kits
Medline medical procedure convenience kits can leak and emit vaporized saline that resembles smoke during use.
6 products
Philips Allura Xper FD10, FD20 and Biplane Systems
Philips Allura Xper systems may have a missing drip tray, allowing coolant to contact electrical components and cause short-circuits.
16 products
Medline Kits With B. Braun IV Administration Sets
Medline kits containing B. Braun IV administration sets may have check valves that stick.
12 products
Medtronic Vanta Clinician Programmer Application
The A71200 Vanta Clinician Programmer Application may not function as intended, potentially causing a prolonged or postponed surgical procedure.
Mobius Imaging AIRO Computed Tomography X-Ray System Pendants
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
2 products
BD Pyxis ES Enterprise Server
BD Pyxis ES Enterprise Server has a software issue that may result in equipment not receiving timely updates of patient, medication, or related information.
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.
