7 results
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52ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code FSO·July 14, 2022
CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures Product Numbers: (1) ROB10000 CORI Starter Kit (2) ROB10024 Real Intelligence CORI (3) ROB10197 CORI STARTER KIT - UNIVERSAL Note: the three product numbers cover the three different configurations in which the CORI Console is sold
FDA Recall
Open, Classified
·Blue Belt Technologies, Inc·Product code OLO·May 7, 2024
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code KPR·January 8, 2020
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2020
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2020
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2020
*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·October 25, 2013