BEUDAMED
    68 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the following device names: LEAD SET WAM 10 WIRE BANANA AHA GRAY, LEAD SET WAM 10 WIRE BANANA IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS BANA AHA GRY, RPLCE LD SET WAM/AM12 LIMBS BANA IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 BANA AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 BANA IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 BANA AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 BANA IEC GRY, LEAD SET AM15E 13-WIRE BANANA AHA GRAY, LEAD SET AM15E 13-WIRE BANANA IEC GRAY, RPLCE LEAD SET AM15E E2-E4 BANANA AHA GRAY, LEAD SET WAM 10 WIRE CLIPS AHA GRAY, LEAD SET WAM 10 WIRE CLIPS IEC GRAY, RPLCE LD SET WAM/AM12 LIMBS CLIP AHA GRY, RPLCE LD SET WAM/AM12 LIMBS CLIP IEC GRY, RPLCE LD SET WAM/AM12 V1-V3 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C1-C3 CLIP IEC GRY, RPLCE LD SET WAM/AM12 V4-V6 CLIP AHA GRY, RPLCE LD SET WAM/AM12 C4-C6 CLIP IEC GRY, LEAD SET WAM/AM12 10-WIRE BANANA AHA GRY, LEAD SET WAM/AM12 10-WIRE BANANA IEC GRY, LD SET WAM/AM12 10 WRE SHORT AHA CLIP, LD SET WAM/AM12 10 WRE SHORT IEC CLIP.

    FDA Recall
    Terminated ·WELCH ALLYN, INC/MORTARA·Product code DPS·March 18, 2020

    Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml.

    FDA Recall
    Terminated ·Instituto Grifols, S.A. # 2 Can Guasch Street, Poligono Levante Parets Del Valles·Product code KPE·November 29, 2005

    ARIES System and ARIES M1 System

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·April 19, 2017

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·June 29, 2018

    ARIES HSV 1&2 Assay, Part Number/REF 50-10017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·April 16, 2021

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·November 17, 2021

    Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·May 1, 2011

    Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·April 6, 2010

    Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Recall
    Terminated ·DICOM GRID INC·Product code LLZ·December 16, 2016

    life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    FDA Recall
    Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

    life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Recall
    Terminated ·GE Healthcare It·Product code LLZ·June 11, 2013

    CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·September 23, 2011

    CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·December 6, 2011

    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011

    Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011

    CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012