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Sources: EU EUDAMED, US FDA
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McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Recall
Terminated
·McKesson Israel Ltd. Or Towers Bldg. B 4, Nehoshet St. Tel Aviv Israel·Product code DQK·March 12, 2018
A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.
FDA Recall
Open, Classified
·Medtronic Neuromodulation·Product code MHY·March 9, 2021
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
FDA Recall
Terminated
·Permobil, Ab Arvaltsvagen 10·Product code ITI·September 1, 2017
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
FDA Recall
Terminated
·Permobil, Ab Arvaltsvagen 10·Product code ITI·September 1, 2017
TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP)
FDA Recall
Terminated
·Abbott Laboratories Inc. (St Jude Medical) One·Product code OAE·April 5, 2019
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body trials is an assembly of the Body and 8 mm Hex Locking Bolt. The trial stem is attached to the trial Cone body via the distal thread of the Locking bolt.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LZO·April 2, 2012
Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
FDA Recall
Terminated
·Mobius Medical Systems, LP·Product code IYE·February 23, 2015
wDR 2.2 Mobile Digital Diagnostic X-Ray System
FDA Recall
Open, Classified
·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·May 23, 2023
EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
FDA Recall
Open, Classified
·Phadia Ab Rapsgatan Plant Rapsgatan 7 Uppsala Sweden·Product code MOB·May 24, 2023
DigitalDiagnost C90, Model No. 712034 and 712035
FDA Recall
Open, Classified
·Philips North America Llc·Product code MQB·May 19, 2023
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card. None of the components, except for the lancets, are sterile. In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
FDA Recall
Terminated
·Alere San Diego, Inc.·Product code GJS·December 5, 2014
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
FDA Recall
Open, Classified
·CHANGE HEALTHCARE CANADA COMPANY·Product code LLZ·November 1, 2023
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
FDA Recall
Open, Classified
·Medtronic MiniMed·Product code MDS·November 21, 2022
System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.
FDA Recall
Terminated
·System 02 Inc
1090 Upper Hembree Rd
Roswell GA 300761140·Product code CAW·May 1, 2003
UniCel DxI 800 Access Immunoassay Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 800 Reconditioned A25285 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·January 26, 2011
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903, DxC860i: A64935, DxC 880i: A59102 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·January 26, 2011
UniCel DxI 600 Access Immunoassay Systems; Part Number(s): DxI 600: A30260, DxI 600 with spot B A71460 The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·January 26, 2011
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002
FDA Recall
Open, Classified
·Phadia US Inc·Product code MST·May 1, 2023
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.
FDA Recall
Open, Classified
·Thoratec Corp.·Product code DSQ·January 3, 2024
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
FDA Recall
Terminated
·Philips North America Llc·Product code JAK·June 8, 2021