Siemens Healthcare Diagnostics Inc: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Agency Publication Date: March 3, 2023

Affected Products

Product: 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 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 1141

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.

Product: 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, ROW 11413518 epoc NXS Host, China-Korea 11413583

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 .

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91639

Status: Active

Manufacturer: Siemens Healthcare Diagnostics Inc

Manufactured In: United States

Units Affected: 2 products (22,156 units; 4,369 units)

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Sources: FDA iRES · Raw API Response

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Affected Products