規制動向

Abbott revises the Amulet™ Left Atrial Appendage Occluder instructions to specify pulmonary artery as a contraindicated adjacent structure and adds guidance on device‑to‑artery distance.

Stryker reports some devices may suffer early battery loss, leading to power issues and coil detachment failure.

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

GE Healthcare reports two potential safety issues affecting order and recording summary components in certain Centricity High Acuity 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 reports blood-to-glycol leakage in the Quantum PureFlow heat exchanger, prompting advisories to users about possible heater‑cooler contamination.

Gentherm Medical reports overheating in 0.53% of devices, potentially causing shutdowns, but no harm reported.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly when AC mains power is lost.

Gentherm Medical reports that 0.53% of Blanketrol RII 115V and RIII 115V devices have overheated circuit boards, potentially causing shutdowns. No injuries reported; users may continue use with caution.

Draeger reports observed hose cracks in VentStar Resus Neo and Resuscitaire; no confirmed patient harm yet.

MHRA warns that several medical devices on the UK market do not meet UK MDR 2002 or EU requirements and must be removed from use and quarantined.