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    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CBK·July 13, 2015

    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code MHX·October 18, 2011

    The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·September 13, 2019

    Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code MHX·December 13, 2012

    Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.

    FDA Recall
    Open, Classified ·Draegar Medical Systems, Inc.·Product code MHX·December 23, 2020

    Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23

    FDA Recall
    Open, Classified ·Draeger Medical Systems, Inc.·Product code MHX·May 13, 2024

    Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·February 21, 2018

    Draeger Infinity Acute Care System Monitoring Solution

    FDA Recall
    Terminated ·Draeger Medical Systems, Inc.·Product code MHX·December 10, 2013

    Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

    FDA Recall
    Terminated ·Draegar Medical Systems, Inc.·Product code MHX·June 6, 2017

    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJG·March 22, 2022

    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJH·March 22, 2022

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024

    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OTE·January 16, 2023

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code MUE·April 8, 2026

    Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-926. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009

    Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir List Number: 265F

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·December 17, 2002

    Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics Cardiovascular Perioperative Autotransfusion System for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code CAC·July 27, 2011

    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 8, 2006

    Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code CAC·January 29, 2008