FDAFDA · Alimentos y medicamentos·N.º oficial Z-2060-2019
MAC VU360, Model Number 2030360-001, Electrocardiograph
Publicado el 31 de julio de 2019 · Inicio del retiro: 28 de junio de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide
- Lote
- UDI # Serial # 840682125499VU218440023SA VU218440023SA 840682125499VU218440030SA VU218440030SA 840682125499VU218450037SA VU218450037SA 840682125499VU218450041SA VU218450041SA 840682125499VU218450042SA VU218450042SA 840682125499VU219170004SA VU219170004SA 840682125499VU219130019SA VU219130019SA 840682125499VU219130032SA VU219130032SA 840682125499VU219130039SA VU219130039SA 840682125499VU219130044SA VU219130044SA 840682125499VU219120048SA VU219120048SA 840682125499VU219120052SA VU219120052SA 840682125499VU219120060SA VU219120060SA 840682125499VU219140016SA VU219140016SA 840682125499VU218440018SA VU218440018SA 840682125499VU219140001SA VU219140001SA 840682125499VU219140005SA VU219140005SA 840682125499VU219120044SA VU219120044SA 840682125499VU219120049SA VU219120049SA 840682125499VU219120054SA VU219120054SA 840682125499VU219120055SA VU219120055SA 840682125499VU219120056SA VU219120056SA 840682125499VU219120012SA VU219120012SA 840682125499VU219120014SA VU219120014SA 840682125499VU219120016SA VU219120016SA 840682125499VU219120018SA VU219120018SA 840682125499VU219190012SA VU219190012SA 840682125499VU219130043SA VU219130043SA 840682125499VU218430051SA VU218430051SA 840682125499VU218430052SA VU218430052SA 840682125499VU218430056SA VU218430056SA 840682125499VU218440007SA VU218440007SA 840682125499VU218440010SA VU218440010SA 840682125499VU218450029SA VU218450029SA 840682125499VU218500017SA VU218500017SA 840682125499VU219040005SA VU219040005SA 840682125499VU219040006SA VU219040006SA 840682125499VU218430014SA VU218430014SA 840682125499VU218430058SA VU218430058SA 840682125499VU218430053SA VU218430053SA 840682125499VU218440026SA VU218440026SA 840682125499VU219140036SA VU219140036SA 840682125499VU219170001SA VU219170001SA 840682125499VU219170002SA VU219170002SA 840682125499VU219170009SA VU219170009SA 840682125499VU219130028SA VU219130028SA 840682125499VU219130035SA VU219130035SA 840682125499VU219130042SA VU219130042SA 840682125499VU219140044SA VU219140044SA 840682125499VU219170005SA VU219170005SA 840682125499VU219180020SA VU219180020SA 840682125499VU219180021SA VU219180021SA 840682125499VU219180022SA VU219180022SA 840682125499VU219180024SA VU219180024SA 840682125499VU219180025SA VU219180025SA 840682125499VU219180026SA VU219180026SA 840682125499VU219180027SA VU219180027SA 840682125499VU219180028SA VU219180028SA 840682125499VU219180029SA VU219180029SA 840682125499VU219180031SA VU219180031SA 840682125499VU219180032SA VU219180032SA 840682125499VU219180035SA VU219180035SA 840682125499VU419170013SA VU419170013SA 840682125499VU219140045SA VU219140045SA 840682125499VU219140047SA VU219140047SA 840682125499VU218430025SA VU218430025SA 840682125499VU219090023SA VU219090023SA 840682125499VU219100057SA VU219100057SA 840682125499VU219110011SA VU219110011SA 840682125499VU219130002SA VU219130002SA 840682125499VU219130003SA VU219130003SA 840682125499VU219130050SA VU219130050SA 840682125499VU219140013SA VU219140013SA 840682125499VU218460002SA VU218460002SA 840682125499VU218500014SA VU218500014SA 840682125499VU218500015SA VU218500015SA 840682125499VU219070022SA VU219070022SA 840682125499VU219080003SA VU219080003SA 840682125499VU219080004SA VU219080004SA 840682125499VU219080006SA VU219080006SA 840682125499VU219090001SA VU219090001SA 840682125499VU219090004SA VU219090004SA 840682125499VU219090008SA VU219090008SA 840682125499VU219090009SA VU219090009SA 840682125499VU219090010SA VU219090010SA 840682125499VU219090012SA VU219090012SA 840682125499VU219090013SA VU219090013SA 840682125499VU219090014SA VU219090014SA 840682125499VU219090015SA VU219090015SA 840682125499VU219090017SA VU219090017SA 840682125499VU219090018SA VU219090018SA 840682125499VU219090020SA VU219090020SA 840682125499VU219090021SA VU219090021SA 840682125499VU219090022SA VU219090022SA 840682125499VU219090024SA VU219090024SA 840682125499VU219090026SA VU219090026SA 840682125499VU219090029SA VU219090029SA 8406821
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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