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FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

Getinge Issues Recall for Cardiohelp Emergency Drive

Getinge is informing about an implemented Class 1 recall for the Cardiohelp Emergency Drive. In total, ten devices were identified. To date, there are no known adverse events associated with serious injury or death. Getinge has reported to relevant competent authorities according to applicable regulations and the cost for the recall is not material.

The Cardiohelp Emergency Drive, which is an accessory to the Cardiohelp-i system, is used in emergencies to manually drive the disposable in case of an unforeseen interfereance or malfunction affecting the Cardiohelp-i system. In total, ten Emergency Drives were located in the United States that possibly were affected, all of which have been identified and corrected.

All concerned customers have received communication and have been provided with a substitute product until the correction is finalized.

This information is released in order to inform users of mentioned Getinge products, according to standard procedure recommended by regulatory authorities. It will also be posted on the FDA website as a Class 1 recall.

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