Siemens Healthcare Diagnostics Inc: epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished

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: 22,156 units Lot/code info: Host Software Version /Sensor Configuration: 3.37.3/41.1 Product Description Siemens Material Number (SMN) Unique Device Identification (UDI-DI) epoc Host 2 10736387 00809708052898; epoc Host 2, Canada 10736388 00809708069117; epoc Host 2, China 10736389 00809708097219; epoc Host 2, Japan 10736390 00809708075576; epoc Host 2, Refurbished 10736393 00809708053901; epoc Host 2, Canada, Refurbished 10736394 00809708069124; epoc Host 2, Japanese, Refurbished 10736395 00809708075583; epoc Host 2, Chinese, Refurbished 10736433 00809708097226; epoc Host 2, US (MC55X) 11413524 00630414606460; epoc Host 2, ROW (MC55X) 11413528 00630414606378; epoc Host 2, India (MC55X) 11413541 00630414608617; epoc Host 2, China (MC55X) 11413542 00630414608624; epoc Host 2, Japan (MC55X) 11413543 00630414608532; epoc Host 2 (MC55X) - US - Refurbished 11413601 00630414615004; "epoc Host 2 (MC55X) - ROW - Refurbished" 11413602 00630414614885; epoc Host 2 (MC55X) - India - Refurbished 1413603 00630414614762; epoc Host 2 (MC55X) - Japan - Refurbished 11413604 00630414614892.

UPC codes

00809708052898, 00809708069117, 00809708097219, 00809708075576, 00809708053901, 00809708069124, 00809708075583, 00809708097226, 00630414606460, 00630414606378, 00630414608617, 00630414608624, 00630414608532, 00630414615004, 00630414614885, 00630414614762, 00630414614892

Source

Official record: FDA (Device enforcement) ↗

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