635 results
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23ms
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Sources: EU EUDAMED, US FDA
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Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
FDA Recall
Terminated
·Medtronic Heart Valves Division·Product code NPT·October 23, 2020
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-23 PRO COMM 29L OUS SA, VLV EVOLUTPRO-23 PRO COMM 29L AUS; b. EVOLUTPRO-23-US, Labeled as: VLV EVOLUTPRO-23-US BLUE COMM US, VLV EVOLUTPRO-23-US PRO BLNK US; c. EVOLUTPRO-26, Labeled as: VLV EVOLUTPRO-26 PRO COMM 29L OUS, VLV EVOLUTPRO-26 BLUE 6L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L AUS, VLV EVOLUTPRO-26 BLUE COMM JPN, VLV EVOLUTPRO-26 BLUE 29L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L CAN, VLV EVOLUTPRO-26 PRO COMM 29L OUS SA; d. EVOLUTPRO-26-US, Labeled as: VLV EVOLUTPRO-26-US BLUE COMM US, VLV EVOLUTPRO-26-US PRO BLNK US; e. EVOLUTPRO-29, Labeled as: VLV EVOLUTPRO-29 PRO COMM 29L OUS, VLV EVOLUTPRO-29 BLUE 29L COMM OUS, VLV EVOLUTPRO-29 BLUE 6L COMM OUS, VLV EVOLUTPRO-29 PRO COMM 29L AUS, VLV EVOLUTPRO-29 BLUE COMM JPN, VLV EVOLUTPRO-29 PRO COMM 29L CAN, VLV EVOLUTPRO-29 PRO COMM 29L OUS SA; f. EVOLUTPRO-29-US, Labeled as: VLV EVOLUTPRO-29-US BLUE COMM US, VLV EVOLUTPRO-29-US PRO BLNK US g. , Labeled as:
FDA Recall
Terminated
·Medtronic Heart Valves Division·Product code NPT·October 23, 2020
GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code DQK·February 2, 2009
Product labeling of the X3 Display reads in part: "XSENSOR Technology Corporation***X3 DISPLAY*** REF: XBOM-002 PID: CTDPDA00 S*** R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada". Product labeling of the X3 PRO reads in part: "XSENSOR Technology Corporation***X3 PRO***REF:XBOM-004 PID: CMUHUB00 S***R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada". Pressure mapping and surface assessment for seats, seat backs, and beds. XSENSOR pressure imaging systems, also known as pressure mapping systems, are a valuable tool in helping clinicians prevent and manage pressure ulcers. Clinicians, nurses, and rehabilitation specialists use XSENSOR pressure imaging systems to help prevent pressure ulcers through improved surface selection and patient positioning on wheelchairs and hospital beds.
FDA Recall
Terminated
·Xsensor Technology Corporation 111·Product code JFC·July 20, 2009
Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX; c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX; d. EVOLUTR-26, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX VLV EVOLUTR-26 VT IR 6L COMM OUS, VLV EVOLUTR-26 TAV EVOLUT R CE 7L MX, LV EVOLUTR-26 TAV CE AU 2Y MX, VLV EVOLUTR-26 TAV JPN MX, VLV EVOLUTR-26 GREY 29L COMM OUS, VLV EVOLUTR-26-US TAV 26 US COMM MX, VLV EVOLUTR-26 TAV CLN OUS MX, VLV EVOLUTR-26 TAV CA 2Y MX, VLV EVOLUTR-26 TAV CE CA 2Y MX, VLV EVOLUTR-26 GREY 6L COMM OUS; e. EVOLUTR-26-C, Labeled as VLV EVOLUTR-26-C TAV EVOLUT R US IDE MEX, VLV EVOLUTR-26-C TAV CLN US MX; f. EVOLUTR-26-US, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-26-US GREY COMM US, VLV EVOLUTR-26-US TAV 26 US COMM MX; g. EVOLUTR-29, Labeled as VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-29 GREY 6L COMM OUS, VLV EVOLUTR-29 VT IR 6L COMM OUS, VLV EVOLUTR-29 TAV CE AU 2Y MX, VLV EVOLUTR-29 TAV JPN MX, VLV EVOLUTR-29 GREY 29L COMM OUS, VLV EVOLUTR-29 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-29 TAV CLN OUS MX, VLV EVOLUTR-29 TAV CA 2Y MX, VLV EVOLUTR-29 TAV CE CA 2Y MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; h. EVOLUTR-29-C, Labeled as VLV EVOLUTR-29-C TAV EVOLUT R US IDE MEX, LV EVOLUTR-29-C TAV CLN US MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; i. EVOLUTR-29-US, Labeled as VLV EVOLUTR-29-US GREY COMM US, VLV EVOLUTR-29-US TAV 29 US COMM MX, VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX; j. EVOLUTR-34, Labeled as VLV EVOLUTR-34 BLUE 29L COMM OUS, VLV EVOLUTR-34 VT IR 6L COMM OUS, VLV EVOLUTR-34 BLUE 6L COMM OUS, VLV EVOLUTR-34 TAV CE AU 2Y MX, VLV EVOLUTR-34 TAV JPN MX, VLV EVOLUTR-34 TAV CLN OUS MX, VLV EVOLUTR-34 TAV CA 2Y MX, VLV EVOLUTR-34 TAV CE CA 2Y MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34 TAV EVO R CE 29L 2Y MX SA, DRAPE 9732722 TUBE STERILE O-ARM 20PK; k. EVOLUTR-34-C, Labeled as VLV EVOLUTR-34-C TAV EVOLUT R US IDE MX, VLV EVOLUTR-34-C TAV CLN US MX; l. EVOLUTR-34-US, Labeled as VLV EVOLUTR-34-US BLUE COMM US, VLV EVOLUTR-34-US TAV 34 US COMM MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34-US TAV 34 US COMM MX SA.
FDA Recall
Terminated
·Medtronic Heart Valves Division·Product code NPT·October 23, 2020
Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·August 27, 2014
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
FDA Enforcement
Class II
·Terminated·Medtronic Heart Valves Division·December 16, 2020
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code JQP·October 25, 2007
BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part /Catalogue Number 086-A001.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code JJE·August 4, 2006
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·August 13, 2014
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·August 13, 2014
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID).
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·August 13, 2014
BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·October 16, 2019