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U.S. Department of Health and Human Services

Class 2 Device Recall Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Prime CCS Analyzer

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 Class 2 Device Recall Stat Profile Prime Abg AnalyzerStat Profile Prime CCS AnalyzerNova Stat Profile Prime CCS Analyzersee related information
Date Initiated by FirmJune 19, 2017
Create DateJuly 13, 2017
Recall Status1 Terminated 3 on August 14, 2018
Recall NumberZ-2732-2017
Recall Event ID 77532
510(K)NumberK131703 K141907 K142220 K151982 
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
ProductNova 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
ActionNova 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 Commerce179 units (US) and 904 (OUS) Total 1083
DistributionWorldwide 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 CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = CHL
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