Recall Z-1215-2023— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-1215-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-12

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2022-12-12. It names one FDA 510(k) clearance: K200107. 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. Reason: pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure.

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-12-12
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K200107 — epoc Blood Analysis SystemEpocal, Inc.·cleared 2020-06-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

Data sourced from openFDA. This site is unofficial and independent of the FDA.