4 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code IXW·April 1, 2016
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·September 15, 2016
SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DHR·June 21, 2010
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code LLZ·April 30, 2021