BEUDAMED
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    Cardiac Workstation 5000; Model Number: 860439;

    FDA Recall
    Open, Classified ·Philips North America·Product code DPS·September 12, 2025

    Cardiac Workstation 7000; Model Number: 860441;

    FDA Recall
    Open, Classified ·Philips North America·Product code DPS·September 12, 2025

    Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code MHX·July 29, 2011

    Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code MHX·July 29, 2011

    OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0

    FDA Recall
    Open, Classified ·Advanced Instruments, LLC·Product code JJM·March 11, 2024

    Azurion 7 M20. X-ray Image guided Therapy System.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·June 12, 2023

    Allura Xper FD10 and FD20. X-ray Imaging System.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·June 12, 2023

    Trilogy Evo Universal, Product number DS2000X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·July 26, 2021

    Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code NOU·July 26, 2021

    Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code NOU·July 26, 2021

    Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code NOU·July 26, 2021

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CGA·December 18, 2014

    Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JQP·October 30, 2013

    IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

    FDA Recall
    Open, Classified ·Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands·Product code LLZ·April 7, 2025

    Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MOI·March 8, 2017

    Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 12, 2013

    Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MOI·March 8, 2017

    Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MOI·March 8, 2017

    Proteus 235; Version: PTS-8 versions before PTS-8.7.2

    FDA Recall
    Terminated ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·November 29, 2021

    Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDI·October 16, 2024