Tag: FDA

FDA recalls BrightView SPECT systems

Editor's Note The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients. Philips sent all affected customers an Urgent Medical Device Correction…

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By: Matt Danford
February 15, 2024
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FDA announces urgent chest drain recall

Editor's Note The FDA has announced a recall of the Atrium Express Dry Suction Dry Seal Chest Drain, a disposable device used to remove air and/or fluid from the chest cavity or mediastinum and to aid in lung expansion and breathing. The drain is being recalled by maker Maquet Cardiovascular,…

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By: Brita Belli
February 9, 2024
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Session: What to expect from healthcare policy, regulation in 2024

Editor's Note Since the pandemic, the view of the healthcare industry in congress has essentially gone from “hero to zero” – a shift with potentially big implications for the healthcare business leaders gathered at yesterday’s closing session from Soumi Saha, PharmD, JD, senior vice president of government affairs at Premier…

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By: Matt Danford
February 8, 2024
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Sonio, AI-powered prenatal ultrasound management solution, announces implementation by Pediatrix MFM Practice

New York, New York (January 31, 2024)–Sonio today announced that Pediatrix Medical Group, the U.S.’s leading provider of highly specialized health care for women, children and babies, has deployed Sonio, a cloud-based, AI-powered prenatal care reporting and image management solution. This new technology is intended to simplify and streamline ultrasound…

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By: Tarsilla Moura
January 31, 2024
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FDA updates safety recall of certain saline, sterile water medical products

Editor's Note The US Food and Drug Administration (FDA) on January 24 updated its safety recall communication from November 6 to add to the voluntary recalls of saline and sterile water medical products associated with Nurse Assist, LLC. The FDA recall notice lists various water-based medical products manufactured by Nurse…

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By: Tarsilla Moura
January 31, 2024
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Blast from the past: Improving medication safety in the OR

The US Food and Drug Administration receives more than 100,000 medication-related reports, and some of them, according to the AORN Journal, “involve patient death.” AORN’s 2024 updated guidelines include safety updates for perioperative staff when handling, transporting, and administering medication, which can be a complex process prone to errors. In…

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By: Tarsilla Moura
January 30, 2024
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Surgeons design implant coating to combat infections

Editor's Note: A point-of-care, antimicrobial coating for orthopedic implants could soon make implant-associated infections a problem of the past, UCLA Health reported on January 3. Developed by two UCLA surgeons, the coating is designed to kill or slow the spread of micro-organisms in order to prevent post-surgical infections. According to…

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By: Matt Danford
January 24, 2024
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FDA safety alert targets shoulder implant packaging

Editor's Note: Equinoxe Shoulder System joint replacement devices manufactured by Exactech between 2004 and 2021 are at risk of premature wearing or failure due to defective packaging, according to a January 16 safety alert from the US Food and Drug Administration (FDA). The bags used to package the devices were…

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By: Matt Danford
January 23, 2024
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FDA warns of chemical exposure from compressor, ventilator combos

Editor's Note:  General Electric (GE) EVair and EVair 03 (Jun-air) air compressors can release dangerous levels of formaldehyde when paired with Carescape R860 and Engström Carestation/Pro ventilators, the U.S. Food and Drug Administration (FDA) warned January 9. Designed to supply the respective ventilators when wall air is not available, the…

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By: Matt Danford
January 12, 2024
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Superpotency concerns spur recall of IV bags for vancomycin, phenylephrine, and fentanyl

Editor's Note:  Englewood, Colo,-based Leiters Health is voluntarily recalling 33 lots of vancomycin, phenylephrine, and fentanyl IV bags due to concerns that they may contain twice the labeled amount of drug, according to a January 8 safety alert from the US Food and Drug Administration (FDA). “The semi-automated IV bag…

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By: Matt Danford
January 11, 2024
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