NEW

Getinge, Cook Medical Reach iCast Distribution Agreement

Getinge and Cook Medical have announced an exclusive sales and distribution agreement for the iCast covered stent system.

Endorail Earns FDA 510(k) clearance: Next-generation magnetic balloon technology optimizes colonoscopy procedural outcomes

Endostart, a pioneering medical device company specializing in gastrointestinal endoscopy solutions, HAS announces a major breakthrough with the FDA 510(k) clearance of its flagship product, Endorail. This achievement represents a significant step forward in advancing...

Survey: Nurse Shortage a Leading Threat to Industry

In honor of Certified Nurses Day, health tech company Carta Healthcare®, whose mission is to harness the value of clinical data, today released the results of a survey about the pain points that health care professionals are currently experiencing. The survey also...

Modular Lab Furniture Systems Meet Needs

UniLine Furniture offerings from HEMCO Corp. include base cabinets, wall cabinets, countertops, sinks, fixtures, base tables, mobile work stations, specialty storage cabinets and peg boards.

Getinge informs about a medical device recall for the Maquet Axius Blower Mister

Getinge is informing about a global Medical Device Recall for the Axius Blower Mister. 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 does not expect the cost for the recall to be material.

The Axius Blower Mister is a contract manufactured product for Getinge. The Axius Blower Mister provides controlled delivery of CO2 and saline during coronary artery bypass surgery. It allows the surgeon to operate a clear bloodless field and complete the anastomosis comfortably. Failure of the Blower mister to deliver a jet of CO2 and saline will impact the ability of the surgeon to complete the anastomosis in a dry bloodless field.

In total 7,880 units of Axius Blower Mister have been distributed globally between September 10, 2018, to January 8, 2019.

All concerned customers have received communication to return the product to Getinge for replacement or credit.

This information is released in order to inform users of mentioned Getinge products, according to applicable requirements by regulatory authorities.

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *

X