Recall Z-2040-2017— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2040-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-10

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2017-04-10, terminated 2019-08-20. It names 2 FDA 510(k) clearances: K113216, K031560. Product: RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306. Reason: Potential Patient Demographic Error with Blank Patient ID Field.

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Terminated: 2019-08-20
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K113216 — RAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare Diagnostics·cleared 2012-05-03
K031560 — BAYER RAPIDLAB 1200 SYSTEMBayer Healthcare, LLC·cleared 2003-12-17

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

RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306

Reason for recall

Potential Patient Demographic Error with Blank Patient ID Field

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