32 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·September 3, 2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·January 3, 2025
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code QNR·October 3, 2025
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Recall
Open, Classified
·Terumo Cardiovascular Systems Corporation·Product code DRY·March 3, 2025
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·December 3, 2025
Azurion 7 M20. Fluoroscopic X-Ray System.
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·June 4, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Recall
Open, Classified
·Fresenius Kabi USA, LLC·Product code FRN·November 3, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Recall
Open, Classified
·Merge Healthcare, Inc.·Product code LLZ·February 19, 2025