| Class 2 Device Recall Siemens RAPIDPoint 405 Blood Gas Analyzer nBili | |
Date Initiated by Firm | August 11, 2016 |
Create Date | September 14, 2016 |
Recall Status1 |
Terminated 3 on July 16, 2020 |
Recall Number | Z-2798-2016 |
Recall Event ID |
74910 |
510(K)Number | K110277 |
Product Classification |
Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
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Product | Siemens RAPIDPoint 405 Blood Gas Analyzer nBili
Siemens Material Number (SMN):
10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 |
Code Information |
All Serial Numbers |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics Inc 2 Edgewater Dr Norwood MA 02062-4637
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For Additional Information Contact | 781-269-3000 |
Manufacturer 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 |
FDA Determined Cause 2 | Software design |
Action | 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 |
Quantity in Commerce | 2910 units |
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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CHL
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