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FDA, EMA, TGA and global regulatory developments

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UPDATED
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 may damage power cables and cause an electrical fault or arc flash risk.
UPDATED
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.
UPDATED
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.
UPDATED
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 and recording summary components in certain Centricity High Acuity systems.
UPDATED
Regulatory Updates
Sep 3, 2026•1 min read
DICOPAC KIT
FDA NDA017406 for DICOPAC KIT, sponsored by GE Healthcare, indicates the product is discontinued and lists its submission history and active ingredients.
UPDATED
Regulatory Updates
Aug 30, 2026•1 min read
GE Healthcare Alerts: CARESCAPE Central Station May Delay Monitoring After Restart
GE Healthcare reports that the CARESCAPE Central Station (CSCS) v3.0.x may not resume patient monitoring for at least three minutes after a system restart.
UPDATED
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.