FDA: Class I recall of certain Datascope/Getinge IABPs
Editor's Note The Food and Drug Administration (FDA) on March 17 identified the recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the coiled cable connecting the display and base on some units may fail,…
Update to Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems
Editor's Note The Food and Drug Administration (FDA) on February 22 updated the Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems. The recall was initiated by GE HealthCare after identifying an issue with two mechanisms that prevent uncontrolled detector movement—a risk that the ball screw, which serves…
FDA: Class I recall of certain Philips Respironics ventilators
Editor's Note The Food and Drug Administration (FDA) on February 16 identified the recall by Philips Respironics of certain reworked Trilogy 100, Trilogy 200, and Garbin Plus ventilators as Class I, the most serious. The recall was initiated because of the potential for silicone foam adhesive failure and residual polyester-based…
FDA: Class I recall of GE HealthCare’s Nuclear Medicine 600/800 Series systems
Editor's Note The Food and Drug Administration (FDA) on February 15 identified the recall by GE HealthCare of its Nuclear Medicine 600/800 Series systems as Class I, the most serious. The recall was initiated because of an issue with two mechanisms that prevent uncontrolled detector movement. If the mechanisms fail,…
FDA: Class I recall of Skippack Medical Lab COVID-19 tests
Editor's Note The Food and Drug Administration (FDA) on February 8 identified the recall by Universal Meditech Inc of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance,…
FDA: Class I recall of Smiths Medical CADD Infusion System Administration Sets, Cassette Reservoirs
Editor's Note The Food and Drug Administration (FDA) on February 2 identified the recall by Smiths Medical of certain CADDTM Infusion System Administration Sets and Cassette Reservoirs as Class I, the most serious. The recall was initiated because of tubing occlusion and false “no disposable attached” alarm issues, which may…
FDA: Class I recall of Medtronic Mahurkar Acute Dual Lumen High Flow Hemodialysis Catheters
Editor's Note The Food and Drug Administration (FDA) on January 30 identified the recall by Medtronic of its Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters (Mahurkar QPlus) as Class I, the most serious. The recall was initiated because of a potential catheter hub defect that may cause…
FDA: Addition to Class I recall of LivaNova LifeSPARC System Controller
Editor's Note The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller. The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System…
Study: Unsafe medical devices gain FDA approval through loophole
Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…
FDA issues warning letters to endoscope manufacturer
Editor's Note The Food and Drug Administration (FDA) on January 10 announced that it had recently issued two warning letters to Olympus Medical Systems Corporation and one of its subsidiaries, Aizu Olympus Co, Ltd, after facility inspections. The letters addressed violations related to medical device reporting (MDR) requirements and quality…
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