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CenTrak Offers Consulting, Training Services

CenTrak has announced the launch of CenTrak Engage. A new release describes CenTrak Engage as “ new expert-led consulting and training services providing a tailored, multi-tiered assessment and transformation program to health care systems. Through practical guidance,...

Countertop Medication Dispensing Cabinet Announced

As part of a line extension, TouchPoint Medical has released a new countertop model of its F series automated medication dispensing cabinet. Any facility that is short on space or budget will benefit from the countertop model, according to a news release. Medication...

Encompass Group Brings eMax Replacement Surfaces to Acute Care

Encompass Group LLC is bringing its line of eMax Replacement Support Surfaces to the acute care market. “With the overwhelmingly positive reception acute care has given our Airisana Therapeutic Support Surface we’re expanding our product offerings in this important...

Getinge clarifies FDA Medical Device recall communication

Following the FDA communication to healthcare providers on June 2, Getinge reinforces guidance that no devices mentioned in the Field Safety Notice need to be returned. On June 8, 2022, FDA revised their published press release, FDA Medical Device Recalls: Atrium...

Getinge clarifies FDA Medical Device recall communication

Following the FDA communication to healthcare providers on June 2, Getinge reinforces guidance that no devices mentioned in the Field Safety Notice need to be returned.

On June 8, 2022, FDA revised their published press release, FDA Medical Device Recalls: Atrium Medical Corporation Recalls iCast Covered Stent (issued June 2, 2022), which classified a voluntary iCast Field Safety Notice (dated April 22, 2022) as a class 1 recall. In the first release, FDA stated “immediately stop using devices from affected lots.” However, this statement was inconsistent with the approved approach agreed upon by Getinge and FDA and has since been removed from the FDA press release to reflect the agreement that no devices need to be returned.

Getinge urges healthcare providers to read the FDA press release in its entirety and click on the link under “Product Lot Numbers: See recall database entry” to see “No Devices Need to Be Returned” in the Action section. Getinge has also created an FAQ on the product and FDA communication that is available on their website at this link.

All impacted customers have received communication from Getinge.

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