LEONI CIA CABLE SYSTEMS - ORION System - Class 2 Recall
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2023 Category: Medical Devices Source Type: alerts
LEONI CIA CABLE SYSTEMS - ORION System - Class 2 Recall
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009 (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 22, 2023 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Cios Flow - Class 2 Recall
The Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment and provides comprehensive image acquisition modes. It consists of a C-arm with X-ray source on one side and flat panel detector on the opposite side, as well as an image display station with a moveable trolley for the image processing and storage system, image display, and documentation. Software modifications since the predicate include system software VA30 modifications (target pointer, digital cine mode, Cios OpenApps), interactive user touch control, dose regulation indicator, new sound radiation delay, new product so...
Source: Medical Device Recalls - October 28, 2023 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Cios Alpha - Class 2 Recall
Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment consisting of a C-arm with X-ray source on one side and flat panel detector on the opposite, as well as an image display station with a moveable trolley. Changes from the predicate include target pointer, interactive user touch control, dose regulation indicator, new sound radiation delay, and new product software security. Material Number: 11105200 (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 28, 2023 Category: Medical Devices Source Type: alerts
Fresenius Kabi USA, LLC - Ivenix Infusion System (IIS), LVP Software; LVPSW0004 - Class 2 Recall
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 26, 2023 Category: Medical Devices Source Type: alerts
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 (titanium dioxide and zinc oxide) lotion [DARPHIN DIST.]
Updated Date: Tue, 22 Aug 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 22, 2023 Category: Drugs & Pharmacology Source Type: alerts
Steris Corporation - LB44 NonSterile Light Handle Cover - Class 2 Recall
Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 29, 2023 Category: Medical Devices Source Type: alerts
Draeger Medical Systems, Inc. - Draeger Infinity CentralStation - Class 2 Recall
Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 28, 2023 Category: Medical Devices Source Type: alerts
ENVIRONMENTAL DEFENSE (zinc oxide) cream [Avasol LLC]
Updated Date: Fri, 21 Apr 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 21, 2023 Category: Drugs & Pharmacology Source Type: alerts
CareFusion 303, Inc. - BD Pyxis - Class 2 Recall
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2023 Category: Medical Devices Source Type: alerts
PURGO AF (benzalkonium chloride) liquid PURGO AF GEL (benzalkonium chloride) gel [Environmental Manufacturing Solutions, LLC.]
Updated Date: Fri, 20 Jan 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 20, 2023 Category: Drugs & Pharmacology Source Type: alerts
ENVIRONMENTAL DETOX (aluminum oxide, barium carbonate, benzene, cadmium, carbon monoxide, carbon disulfide, copper, wood creosote, mercurius solubilis, strychnos nux-vomica seed, lead acetate anhydrous, solidago virgaurea flowering top, sulfur iodide, thuja occidentalis leafy twig) liquid [Groupe Cyrenne Inc.]
Updated Date: Fri, 20 Jan 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 20, 2023 Category: Drugs & Pharmacology Source Type: alerts
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 (titanium dioxide and zinc oxide) lotion [DARPHIN DIST.]
Updated Date: Fri, 30 Dec 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 30, 2022 Category: Drugs & Pharmacology Source Type: alerts
ENVIRONMENTAL DETOX (aluminum oxide, barium carbonate, benzene, cadmium, carbon monoxide, carbon disulfide, copper, wood creosote, mercurius solubilis, strychnos nux-vomica seed, lead acetate anhydrous, solidago virgaurea flowering top, sulfur iodide, thuja occidentalis leafy twig) liquid [Groupe Cyrenne Inc.]
Updated Date: Mon, 26 Dec 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 26, 2022 Category: Drugs & Pharmacology Source Type: alerts
AERISGUARD ACTISAN HAND SANITIZER (benzalkonium chloride) solution [Aeris Environmental LLC]
Updated Date: Tue, 13 Dec 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 13, 2022 Category: Drugs & Pharmacology Source Type: alerts
