192 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 22, 2013
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MQB·February 4, 2011
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
FDA Recall
Terminated
·Alcon Research, Ltd.·Product code HQL·September 29, 2015
GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code OWB·December 20, 2011
GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·March 20, 2013
Spectrum IQ Infusion System with Dose IQ Safety Software
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·October 28, 2020
OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed by : LifeScan, Inc. Milpitas, CA 95035 for: LifeScan Europe Division of Cilag GmBH International 6300 Zug Switzerland Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood.
FDA Recall
Terminated
·Lifescan Inc·Product code LFR·February 21, 2012
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·October 24, 2018
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·August 18, 2021
Dose IQ Safety Software used with Spectrum IQ Infusion Pump
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FRN·July 7, 2021
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ Verio IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ Verio IQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
FDA Enforcement
Class I
·Terminated·Lifescan Inc·April 24, 2013
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FRN·June 4, 2021
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·March 11, 2013
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
FDA Enforcement
Class I
·Terminated·Alcon Research, Ltd.·December 2, 2015
GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code LLZ·June 11, 2008
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
FDA Enforcement
Class I
·Terminated·Baxter Healthcare Corporation·August 18, 2021
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAA·April 16, 2009
Spectrum IQ Infusion System with Dose IQ Safety Software
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FRN·June 30, 2020
SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code PHC·September 18, 2018