FDA Blocks Entry of Certain Olympus Devices Over Quality Concerns
Certain import devices from Olympus’ Aizu facility in Japan will be refused entry due to outstanding quality system violations, the FDA says.
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Search Results for: recall
GE HealthCare Recalls Certain Carestation Devices Over Ventilation Risk
The Carestation anesthesia systems are being recalled due to a risk of ineffective ventilation in volume control mode, which could lead to serious injury or death.
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Medtronic Recalls Certain Newport Ventilators and Related Service Parts
Customers are being asked to remove the affected devices from use and replace with an alternate means of ventilation.
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Zyno Medical Recalls Infusion Pumps Over Software Issue
Certain Z-800 series infusion pumps may malfunction due to unverified software, prompting a Class I recall by the FDA.
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New VR Training Combats Contamination of Portable Medical Equipment
A new VR training tool developed by Mass General Brigham aims to reduce contamination from portable medical devices through immersive, gamified instruction.
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