Siemens RAPIDPoint 405 Cl II

Company: Siemens Healthcare Diagnostics, Inc.
Date of Enforcement Report 9/21/2016
Class lI:

PRODUCT

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

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/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Norwood, MA on 9/14 2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2910 units

DISTRIBUTION
Nationwide and Internationally

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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.