RecallDepth

Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306

Company
Siemens Healthcare Diagnostics Inc
Recall Initiated
August 11, 2016
Terminated
July 16, 2020
Recall Number
Z-2799-2016
Quantity
6786 units
Firm Location
Norwood, MA

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

Distribution

Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. United Kingdom Uruguay Vatikancity Vietnam

Lot / Code Info

All Serial Numbers

Root Cause

Software design

Action Taken

Siemens Healthcare issued Urgent Field Safety Notice to (US) customers via Federal Express. . All affected customers outside the US provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs customers of the issue, Actions to be Taken by the Customer and to return the response form. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative

More recalls by Siemens Healthcare Diagnostics Inc

View all recalls by this company →