Lazurite Submits FDA 510(k) for ArthroFree Wireless Camera System

Medical device and technology company Lazurite Holdings LLC has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its ArthroFree wireless camera system for minimally invasive surgery, and that the submission has been accepted...

Titan Medical Selects Benchmark to Manufacture Enos Robotic Single Access Surgical System

Titan Medical Inc., a medical technology company focused on the design and development of innovative surgical technologies for robotic single access surgery, announced today that it has signed a manufacturing and supply agreement with Benchmark Electronics, Inc. to...

National Medical Billing Services Announces Acquisition of mdStrategies

National Medical Billing Services (National Medical), an industry leading healthcare revenue cycle management company serving the ambulatory surgery center market, has acquired mdStrategies, a full-service medical coding company focused on ASCs. The combination will...

RTI Surgical Becomes Two Independent Companies

RTI Surgical will spin off its metals business, creating two independent companies that are focused on the needs of customers and patients in distinct market segments. Ownership of both companies will be retained by Montagu, a private equity firm.

Getinge Announces Medical Device Recall

Getinge has announced a global medical device recall related to specific Sevoflurane vaporizers for Flow Family Anesthesia systems. To date, no patient or operator adverse events have been reported. Getinge has reported to relevant authorities according to applicable regulations and is now informing affected customers about the issue through a field safety notice/recall. The cost for the field action is not material.

The vaporizer is the unit containing anaesthetic agent and is available for the anaesthetic agents Sevoflurane, Desflurane and Isoflurane. This issue is only applicable for specific Vaporizers used for certain types of Sevoflurane, which is used as an inhalational anesthetic for induction and maintenance of general anesthesia.

Getinge has received eight complaints describing the presence of a yellow substance in the vaporizer. This issue has only been observed when using certain types of Sevoflurane. No patient or operator adverse events have been reported in any of these complaints.

Getinge will continue to investigate and will provide an update once the root cause and/or corrective actions are identified. Customers are requested to follow the instructions in the field safety notice/ field correction notice until further communication from Getinge.

This information is released in order to inform users of mentioned Getinge products, according to standard procedure recommended by regulatory authorities.



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