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FDA (Device enforcement)Recalled 2022-12-12class ii

Siemens Healthcare Diagnostics Inc: epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host

Hazard

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Details from the source

Reason for recall: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure Distribution: Nationwide Foreign: Algeria Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Cambodia Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Guadeloupe Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kuwait Laos Latvia Lithuania Luxembourg Malaysia Mali Quantity: 4,369 units Lot/code info: Host Software Version /Sensor Configuration: 4.10.6/41.1 Product Description Siemens Material Number (SMN) (UDI-DI) epoc NXS Host, US 11413475 00630414606095; epoc NXS Host, EU 11413497 00630414605760; epoc NXS Host, Japan 11413498 00630414605814; epoc NXS Host, Canada 11413506 00630414605821; epoc NXS Host, ROW 11413518 00630414605678; epoc NXS Host, China-Korea 11413583 00630414612447 .

UPC codes

00630414606095, 00630414605760, 00630414605814, 00630414605821, 00630414605678, 00630414612447

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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