Endoscope manufacturer Olympus Medical receives third warning from FDA
Editor's Note The FDA on March 15 issued its third warning letter to endoscope manufacturer Olympus Medical, following a manufacturing site inspection and 160 complaints of device failure, as reported by Beckers. The warning letter comes after a Tokyo, Japan facility inspection, where the Single-Use Distal Covers for Duodenoscopes and…
FDA updates list of COVID-19 device shortages, discontinued devices
Editor's Note The Food and Drug Administration (FDA) on March 16 updated its list of COVID-19 medical device shortages to reflect changes in estimated shortage durations during the public health emergency. These include: Radiological devices General plastic surgery devices Cardiac diagnostic and monitoring products General ICU/hospital products Specimen collection, testing…
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…
Free Daily News
- Study: Systemic gender bias embedded in surgical practice
- Literature review: Endoscope disinfection failures highlight need for stronger sterilization practices
- Study: GLP-1 drugs heighten risk of gastric residue but not perioperative pulmonary aspiration
- OAS CAHPS compliance soars to 96% among ASCs, vendor satisfaction also improves
- Knee surgical robot market set to surge, projected to reach $5.9B by 2032
- Health system mega-mergers fall short amid cost, quality concerns
- Health systems boost security spending as workplace violence escalates
- Strengthening healthcare cyber defenses challenged by third-party, asset-related risks
- Healthcare’s “Blockbuster Moment:” Dr Dan Weberg to deliver opening keynote address at OR Manager Conference
- Hospital staffing report: Nurse turnover eases but vacancies, costs remain high