Regulatory Updates
Sep 24, 2026•1 min read
Stryker devices may experience premature battery drain, affecting operation
Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.
Regulatory Updates
Sep 18, 2026•1 min read
GE Healthcare Alerts on Exposed Sharp Edge in SIGNA™ Artist Cabinets
GE Healthcare reports an exposed sharp edge inside SIGNA™ Artist and Artist Evo electronics cabinets that could damage power cables and cause an arc flash injury.
Regulatory Updates
Sep 17, 2026•1 min read
STERIS issues alert on RAPICIDE™ Part A bottles swelling in certain lots
STERIS reports that some RAPICIDE™ Part A bottles may bulge due to blocked vent caps, posing a risk of off‑gassing and exposure if PPE is not used.
Regulatory Updates
Sep 16, 2026•1 min read
Medtronic Identifies Reflective Material Variation in Sterile Passive Spheres
Health Canada reports a limited number of Medtronic sterile passive spheres have variable reflective coating that could affect navigation system tracking.
Regulatory Updates
Sep 10, 2026•1 min read
GE Healthcare alerts on two potential issues in Centricity High Acuity systems
GE Healthcare reports two potential safety issues affecting order summary components in certain Centricity High Acuity anesthesia systems.
Regulatory Updates
Sep 9, 2026•1 min read
Philips Unity & BV Pulsera Mobile C-Arm Systems May Experience X-ray Failure Due to Air Bubbles
Air bubbles in the monoblock oil of Philips Unity and BV Pulsera mobile C‑arm systems can cause X‑ray generation failure, displaying an error and requiring a restart.
Regulatory Updates
Sep 4, 2026•1 min read
Health Canada Alert: Stryker LifePak R35 Connector Seating Issue
Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.
Regulatory Updates
Sep 4, 2026•1 min read
Gore VIABAHN® Device Quality Issue Identified
Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.
Regulatory Updates
Aug 30, 2026•1 min read
GE Healthcare CARESCAPE Central Station v3.0.x May Delay Monitoring After Restart
GE Healthcare reports that its CARESCAPE Central Station v3.0.x may fail to resume patient monitoring for at least three minutes after a system restart.
Regulatory Updates
Aug 23, 2026•1 min read
Health Canada Alert: Aisys™ Anesthesia Systems to Alternate O₂ Control
Health Canada alerts that Aisys™ Carestation™, Aisys™ CS² and CS² with Et Control anesthesia systems may automatically switch to Alternate O₂ Control due to certain electronic gas mixer assemblies.