5 results
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44ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code MUQ·October 5, 2021
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·February 25, 2022
REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
FDA Recall
Open, Classified
·Cellavision AB Forskningsbyn Ideon Scheelevagen 19a Lund Sweden·Product code JOY·October 8, 2025