30 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code OCC·May 17, 2016
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
FDA Enforcement
Class III
·Terminated·Roche Molecular Systems, Inc.·July 20, 2016
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Recall
Terminated
·LumiraDx·Product code QKO·June 24, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Enforcement
Class II
·Terminated·LumiraDx·July 27, 2022
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Enforcement
Class III
·Terminated·LumiraDx·November 2, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
FDA Recall
Terminated
·LumiraDx·Product code QKO·June 24, 2022
RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. [email protected] RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·October 19, 2011
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 3, 2015
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·December 25, 2013
Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden
FDA Recall
Terminated
·MAQUET Inc.·Product code BSZ·July 10, 2007
S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
FDA Recall
Terminated
·Advanced Bionics LLC·Product code MCM·July 24, 2008
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·May 8, 2015
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
FDA Recall
Terminated
·LumiraDx·Product code QKP·September 23, 2022
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OSU2FUS
FDA Recall
Terminated
·Arjo, Inc.·Product code FSG·January 5, 2007
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4MSU2FUS
FDA Recall
Terminated
·Arjo, Inc.·Product code FSG·January 5, 2007
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS
FDA Recall
Terminated
·Arjo, Inc.·Product code FSG·January 5, 2007
Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS
FDA Recall
Terminated
·Arjo, Inc.·Product code FSG·January 5, 2007
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·May 9, 2012
ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·October 15, 2007
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
FDA Recall
Terminated
·Leica Microsystems (Schweiz) Ag 201 Max Schmidheiny-Strasse Heerbrugg Switzerland·Product code FSO·December 18, 2012