13 results
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30ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code JJE·December 5, 2018
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an automation line. System Name/ Catalog Number: DxC 660i/ A64871, DxC 680i /A64903, DxC 860i /A64935, DxC 880i /A59102
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code JJE·December 5, 2018
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
FDA Recall
Open, Classified
·Volcano Corporation·Product code OWB·January 19, 2022
Philips Spectral CT on Rails. Model Number: 728334.
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS·Product code JAK·March 7, 2026
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
FDA Recall
Open, Classified
·Beckman Coulter Inc.·Product code CGR·August 4, 2025
Philips Respironics V60 Plus Ventilator Part Number 1138747
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·January 24, 2022
Philips Respironics V60 Ventilator Part Number 1053617
FDA Recall
Open, Classified
·Respironics California, LLC·Product code MNT·January 24, 2022
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
FDA Recall
Open, Classified
·Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom·Product code MWJ·November 25, 2024
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
FDA Recall
Open, Classified
·Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom·Product code MWJ·November 25, 2024
DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·April 18, 2024
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code CFP·November 21, 2023
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·November 21, 2023
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01, 111-206-01, 107-245-01, 107-246-01; BD Pyxis CII Safe, Software: V9, REF: 107-252-01, 111-215, 111-216, 111-219, 111-221. BD Pyxis CII Safe, Software: ES, REF: 107-254-01, 107-255-01, 1116-00, 1117-00; BD Pyxis CII Safe, Software: N/A, REF: 111-113, 111-114, 111-115, 111-160-201, 111-217, 111-218, 111-220, 111-222; Tripp Lite SUPER6TEL Surge Suppressor, REF: CN 200-025. Used with BD Pyxis CII Safe System: v7.x for WES7 User Guide, DIR 10000145747/ v8.1 User Guide, DIR 10000277635/v9.0 User Guide, DIR 10000354270/ ES User Guide v1.8, DIR 10000418517
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·May 22, 2023