Recall Z-2797-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2797-2016
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: K002738. Product: Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634. 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

K002738 — BAYER RAPIDPOINT 400 SYSTEMBayer Corp.·cleared 2000-12-19

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

Siemens RAPIDPoint¿ 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634

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.