BEUDAMED
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    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·August 13, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·April 1, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FPO·May 12, 2021

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code HIG·April 9, 2026

    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

    FDA Recall
    Open, Classified ·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023

    VITROS XT Chemistry Products TBIL-ALKP Slides

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code CIG·August 5, 2023

    Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CIG·July 30, 2024

    Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

    FDA Recall
    Open, Classified ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·June 18, 2021

    Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479

    FDA Recall
    Open, Classified ·ConvaTec, Inc·Product code EXE·November 29, 2024

    Medline procedural kits labeled as: 1) AFCH ANTERIOR SEGMENT PK, Pack Number DYNJ63330B ; 2) ANTERIOR HIP PACK , Pack Number DYNJ82317; 3) ARTHROGRAM, Pack Number DYNDH1446A ; 4) ARTHROGRAM TRAY, Pack Number DYNDH1648; 5) ARTHROGRAM TRAY, Pack Number PAIN1396 ; 6) ARTHROGRAM TRAY , Pack Number DYNDH1648; 7) ARTHROGRAM TRAY , Pack Number PAIN1396 ; 8) ARTHROGRAM/ASPIRATION RADIOLOG, Pack Number DYNJRA2152 ; 9) ARTHROGRAPH TRAY, Pack Number MNS12670B; 10) ARTHROSCOPY , Pack Number DYNJ909699 ; 11) GLMI ARTHROGRAM KIT: BIG TREE , Pack Number DYNDH1752; 12) HANA TABLE, Pack Number DYNJ908424A; 13) JC HIP ARTHROSCOPY, Pack Number DYNJ907481 ; 14) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480 ; 15) JC KNEE ARTHROSCOPY , Pack Number DYNJ907480A; 16) JC SHOULDER ARTHROSCOPY , Pack Number DYNJ907479A; 17) LUMBAR DRAIN PACK , Pack Number DYNJ67379; 18) LUMBAR DRAIN PACK , Pack Number DYNJ67379H ; 19) OPEN SHOULDER CDS , Pack Number CDS983316D ; 20) ORTHO SPINE PACK, Pack Number DYNJ59720A ; 21) ORTHO SPINE PACK, Pack Number DYNJ59720B ; 22) PODIATRY TRAY-LF, Pack Number DYNJ51178D ; 23) TOTAL KNEE CDS-LF , Pack Number CDS940845L ; 24) TOTAL KNEE CDS-LF , Pack Number DYNJ907028 ; 25) TOTAL KNEE CDS-LF , Pack Number DYNJ907028A; 26) TOTAL KNEE CDS-LF , Pack Number DYNJ907028C

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·April 8, 2024

    Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

    FDA Recall
    Open, Classified ·Cartiva, Inc·Product code PNW·October 31, 2024