Recall Z-2798-2016— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-2798-2016
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: K110277. Product: Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784. 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

K110277 — RAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare Diagnostics·cleared 2011-08-15

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 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784

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.