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    vRad PACS with Mammography

    FDA Recall
    Open, Classified ·Virtual Radiologic Corp.·Product code LLZ·May 9, 2023

    RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·March 4, 2020

    Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0, 10.0.0, 10.0.1, 10.0.2, 10.1.0, 10.1.1, 11.0.0, 11.0.1, 11.0.3, 11.0.4, 12.0.0, 12.1.0, 12.1.1, 12.0.3, 12.1.2, 12.0.4, 12.1.3, 13.0.0, 13.1.0. Software Version Numbers 9A, 9B, 10A, 10B, 11A, 11B and 12A including service packs

    FDA Recall
    Open, Classified ·RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden·Product code MUJ·February 17, 2023

    Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code EOQ·October 18, 2023

    Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code EOQ·October 18, 2023

    Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code EOQ·October 18, 2023

    BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc·Product code LJT·January 15, 2020

    Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code DQK·July 3, 2024

    AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2

    FDA Recall
    Open, Classified ·GE Medical Systems, SCS·Product code LLZ·September 5, 2025

    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

    FDA Recall
    Open, Classified ·Covidien LLC·Product code MWI·January 30, 2026

    Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.

    FDA Recall
    Open, Classified ·Kico Knee Innovation Company·Product code SBF·September 19, 2025

    Description/REF: PICC ACCESS TRAY/ASK-04001-CG1

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LJT·April 21, 2026

    Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, ASK-09458-VU

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code POZ·April 21, 2026

    Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LDF·April 21, 2026

    Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OWL·March 11, 2026

    PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code PYC·April 21, 2026

    Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code GBW·April 21, 2026

    Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code LFJ·April 21, 2026

    Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code PND·April 21, 2026

    Description/REF: ACCESS TRAY/ASK-04001-MC3

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code PXB·April 21, 2026