Date Initiated by Firm | June 19, 2017 |
Create Date | July 13, 2017 |
Recall Status1 |
Terminated 3 on August 14, 2018 |
Recall Number | Z-2732-2017 |
Recall Event ID |
77532 |
510(K)Number | K131703 K141907 K142220 K151982 |
Product Classification |
Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
|
Product | Nova Biomedical Stat Profile Prime Analyzer as follows:
PN 52855 Stat Profile Prime ABG Analyzer
PN 53655 Stat Profile Prime ABG Analyzer with Scanner
PN 52856 Stat Profile Prime CCS Analyzer
PN 53656 Stat Profile Prime CCS Analyzer with Scanner
PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner
PN 52857 Stat Profile Prime CCS Comp Analyzer
Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer |
Code Information |
All current software versions |
Recalling Firm/ Manufacturer |
Nova Biomedical Corporation 200 Prospect St Waltham MA 02453-3457
|
For Additional Information Contact | 781-647-3700 |
Manufacturer Reason for Recall | Software- scheduled A-QC analysis could initiate prior
to a patient result being released by the operator and result in the pending patient result being overwritten
with the A-QC test results. |
FDA Determined Cause 2 | Software design |
Action | Nova Biomedical issued Urgent Field Correction Notice on June 19, 2017, to all affected customers. The letter advises users of the problem and Nova Biomedical or an authorized Nova Biomedical representative will schedule a no charge update of your Stat Profile Prime Analyzer software to version VI1.0.883.0. A representative will contact customers to schedule this update. Questions: contact Nova Biomedical Technical Support at 1-800-545-6682, in Canada contact us at 1-800-263-5999, or outside of N. America contact your authorized Nova Biomedical subsidiary or distributor.
For questions regarding this recall call 781-647-3700. |
Quantity in Commerce | 179 units (US) and 904 (OUS) Total 1083 |
Distribution | Worldwide Distribution - US (Nationwide)
Foreign:
Albania
Algeria
Argentina
Australia
Austria
Bangladesh
Benin
Bolivia
Brazil
Canada
Chile
China
Colombia
Costa Rica
Czech Republic
ECUADOR
Egypt
El Salvador
Finland
France
Germany
Ghana
Greece
Guatemala
Guyana
Honduras
Hong Kong
Hungary
ICELAND
India
Iran
Israel
Italy
Ivory Coast
Japan
Jordan
Kenya
Korea
Latvia
Macedonia
Malaysia
Mexico
Nepal
Netherlands
Nigeria
Pakistan
Pakistan
Palestine
Peru
Philippines
Poland
Puerto Rico
Republic of Panama
Republica Dominicana
Russia
Saudi Arabia
Slovak Republic
Slovenia
South Africa
Sri Lanka
Switzerland
Taiwan
Thailand
The Netherlands
Trinidad,W.I.
Tunisia
Turkey
UK
Uruguay
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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