規制動向
2026年9月25日•1分で読めます
Abbott Updates Amulet IFU to Highlight Pulmonary Artery Risk
Abbott has revised the instructions for use of its Amplatzer Amulet left atrial appendage occluder to specifically contraindicate placement near the pulmonary artery and added guidance on distance assessment.
規制動向
2026年8月30日•1分で読めます
Health Canada issues alert on Pro+ model p7924a13 labeling error
The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.
規制動向
2026年8月30日•1分で読めます
Stryker Issues Recall of StrykeFlow PS Handpiece Over Leak Complaints
Cardinal Health reports a Stryker recall of the StrykeFlow PS device due to multiple complaints of handpiece leakage during use.
規制動向
2026年8月23日•1分で読めます
Health Canada Recall: Inaccurate StO2 Readings from Edwards ForeSight™ Oximeter Cable
Edwards reports mislabelled sensor cables on the ForeSight™ Oximeter Cable may cause swapped left/right StO2 values, risking misdiagnosis.