Category: Safety

Safety

FDA Issues Warning Letter to Zoll Medical Over Quality System Violations

The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.

Safety

MITRE Report Outlines Cybersecurity Risks for Medical Devices Using AI and Cloud

The analysis identifies emerging threats to patient safety and device performance as manufacturers adopt new technologies and advanced encryption.

Safety

Stryker Hit by Cyberattack Linked to Iran-Tied Hacking Group, Causing Global Network Outage

The attack, attributed to pro-Palestinian hacking group Handala, reportedly wiped Windows devices across Stryker's enterprise environment and disrupted ordering systems.

Cybersecurity

Survey Reveals Disconnect Between Hospital Cybersecurity Goals and IoMT Device Risk Management Practices

43% of hospital security leaders name IoMT visibility as their top cybersecurity challenge, while internal process issues create the biggest obstacle to effective risk management.

Medical Device Errors

How Gaps in Requirements Traceability Fuel Recalls and Injuries

Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.

Fire Safety

Patient Dies After Defibrillator Fire at Tennessee Hospital

A patient using a defibrillator died at a southern-based medical center after the device erupted in fire and burned his body.

Hospital Safety

New Hospital Visitor System Features ‘Always-On’ Offline Capability

Managed from an Apple iPad, the system is designed to maintain visitor check-in, logging, and badge printing functions even during internet or power outages.