Regulatorische Updates

Stryker reports that some devices can suffer premature battery drain, leading to power failures, weak indicators, or coil detachment issues.

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.

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.

Health Canada reports a limited number of Medtronic sterile passive spheres have variable reflective coating that could affect navigation system tracking.

GE Healthcare reports two potential safety issues affecting order summary components in certain Centricity High Acuity anesthesia systems.

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.

Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.

Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.

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.

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.