Recall Z-2801-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2801-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-11

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2016-08-11, terminated 2020-07-16. It names one FDA 510(k) clearance: K031560. Product: RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393. Reason: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system.

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-11
Terminated: 2020-07-16
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

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

RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393

Reason for recall

There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system

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