FDAFDA · Alimentos y medicamentos·N.º oficial Z-2340-2018
GE Healthcare CARESCAPE Monitor B650
Publicado el 11 de julio de 2018 · Inicio del retiro: 25 de mayo de 2018
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare Finland Oy
- Distribuidor
- worldwide
- Lote
- Serial Numbers: SEW13497373HA SEW13497374HA SEW13497375HA SEW13497376HA SEW13508068HA SEW12494591HA SEW14280294HA SEW14280298HA SEW14289769HA SEW14289777HA SK416341018HA SK416341019HA SK416341026HA SEW12494422HA SEW12494425HA SEW12494435HA SEW12494584HA SEW12494585HA SEW12494592HA SEW12494593HA SEW12494596HA SEW12494598HA SEW12494619HA SEW12494621HA SEW12494622HA SEW12494625HA SEW12494626HA SEW12504918HA SEW12504923HA SEW12504940HA SEW12504942HA SEW12504944HA SEW12504954HA SEW14278996HA SEW14279002HA SEW14279003HA SEW14279005HA SK416061047HA SK416061048HA SK416061088HA SK416081102HA SK416461063HA SK416461092HA SEW13109786HA SEW12059577HA SEW12059583HA SEW12059587HA SEW12059589HA SEW12059592HA SEW12059593HA SEW12059594HA SEW12059596HA SEW12059597HA SEW12059598HA SEW12059599HA SEW12059601HA SEW13275956HA SEW13276028HA SEW13276029HA SEW13275967HA SEW13276066HA SEW13276073HA SEW13286164HA SEW13286175HA SEW13286183HA SK415491246HA SK415491249HA SK415491253HA SK415491257HA SK415491259HA SK415491264HA SK415491265HA SQC17490035HA SQC17490038HA SQC17490039HA SQC17490040HA SQC17490042HA SEW15134264HA SEW15134269HA SEW15134270HA SK415211108HA SK415211110HA SK415211116HA SK415221002HA SK415221006HA SK415361118HA SK415361119HA SK415361120HA SK415361121HA SK415361122HA SK415361123HA SK416041059HA SK416051085HA SK416051119HA SK416041053HA SK416041054HA SK416041062HA SK416041063HA SK416041065HA SK415491254HA SK415521029HA SK415531048HA SK416011088HA SK416011113HA SK416501112HA SK416501119HA SK416501122HA SK417051035HA SK417051036HA SK417051038HA SK417051099HA SK417051100HA SK417051118HA SK417051121HA SK417051122HA SK417051125HA SK417051126HA SK417051130HA SK417051131HA SK417051139HA SK417051144HA SK417051145HA SK417051149HA SK417051150HA SK417051151HA SK417051152HA SK417051153HA SK417051154HA SK417051157HA SK417061002HA SK417061023HA SK417061024HA SK417061025HA SEW13508579HA SEW13369186HA SEW13369234HA SEW13369245HA SEW13369246HA SEW13369249HA SEW13369251HA SEW13369252HA SEW13369254HA SEW13369255HA SEW13369256HA SEW14381680HA SEW15166221HA SEW15166222HA SEW15166223HA SEW15166224HA SEW15166226HA SEW15166230HA SEW15166231HA SEW15166235HA SEW15166236HA SEW15166237HA SEW14063178HA SEW14062864HA SEW14062865HA SEW14062927HA SEW14063174HA SEW14063175HA SEW14063176HA SEW14063179HA SEW14062866HA SEW14235956HA SEW14235957HA SEW14235958HA SEW14235993HA SEW14235994HA SEW14235995HA SEW14246223HA SK416051106HA SK416051113HA SK416051114HA SK416051115HA SEW11202291HA SK416121077HA SK416121083HA SEW12245068HA SEW12245071HA SEW12245072HA SEW12245074HA SEW12245075HA SEW12245076HA SEW12482932HA SQC18150040HA SQC18150042HA SK416321071HA SK416321073HA SK416321075HA SK416321076HA SEW13317664HA SQC17500211HA SQC17500212HA SQC17500213HA SQC17500214HA SQC17500215HA SQC17500216HA SQC17500217HA SQC17500218HA SQC17500219HA SQC17500220HA SQC17500221HA SQC17500222HA SQC17500224HA SQC17500225HA SQC17500226HA SQC17500228HA SQC17500230HA SQC17500234HA SQC17500235HA SEW14063243HA SQC18010001HA SK417081005HA SEW13369260HA SEW13369277HA SEW13379768HA SEW13379778HA SEW13379779HA SEW13379780HA SEW13379782HA SEW13379784HA SEW13379790HA SEW13379791HA SEW14031040HA SEW14031041HA SEW14031042HA SEW14031044HA SEW14031045HA SEW14031046HA SEW14031047HA SEW14031060HA SEW14031061HA SEW14031062HA SEW14031066HA SEW14041261HA SEW14041262HA SEW14041263HA SEW14041264HA SEW14041267HA SEW14041268HA SEW14041269HA SEW14041271HA SEW14041282HA SEW14041283HA SEW14041284HA SEW14041286HA SEW14041287HA SEW14041289HA SEW14041290HA SEW14041291HA SEW14063210HA SEW14105484HA SEW14105968HA SEW14105969HA SEW14116795HA SEW14127301HA SEW14127307HA SEW14127308HA SEW14127312HA SEW14127313HA SEW14127314HA SEW14127315HA SEW14127316HA SEW14127317HA SEW1412
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Finland
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