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U.S. Department of Health and Human Services

Class 2 Device Recall RAPIDPoint 500 Blood Gas Analyzer

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  Class 2 Device Recall RAPIDPoint 500 Blood Gas Analyzer see related information
Date Initiated by Firm April 10, 2017
Create Date May 05, 2017
Recall Status1 Terminated 3 on August 20, 2019
Recall Number Z-2040-2017
Recall Event ID 76981
510(K)Number K113216  K031560  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
Siemens SMN numbers: 10492730, 10696857, 10697306
Code Information Serial Numbers: 30762 32470 33999 35395 36284 39672 40405 40456 40508 30779 33198 34000 35462 37243 39688 40406 40460 40509 30784 33201 34082 35688 37261 39689 40407 40461 40510 30819 33232 34083 35690 37275 39690 40408 40464 40512 30841 33370 34291 35692 37292 39691 40409 40466 40561 30842 33438 34427 35693 37295 39692 40410 40467 40562 30844 33459 34438 35703 37296 39693 40411 40468 40565 30846 33573 34442 35705 37563 39694 40412 40469 40568 30904 33640 34444 35922 38110 39695 40413 40470 40576 30905 33643 34627 36003 38138 39698 40421 40471 40580 30906 33863 35002 36005 38306 39699 40422 40473 40582 30907 33865 35009 36006 38815 39700 40427 40477 40583 31006 33968 35053 36007 39301 39701 40436 40489 40594 31771 33986 35055 36008 39303 39702 40437 40501 40596 31772 33997 35195 36113 39459 39703 40448 40502 40612 32356 33998 35393 36116 39597 40403 40451 40503 40616 40624 40625 40642 40643 40644 40647 40648 40666 40669 40677 40678 40679 40748 40806 313388
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact
781-269-3000
Manufacturer Reason
for Recall		 Potential Patient Demographic Error with Blank Patient ID Field
FDA Determined
Cause 2		 Software design
Action Siemens Healthcare issued an An Urgent Field Safety Notice via e-mail to all affected Siemens Healthcare Diagnostics Regional offices on April 10, 2017 both in the United States and outside of the United States. This notice informs customers of the issue, risk to health and actions to be taken by the customer. A Field Correction Effectiveness Check form to be completed and returned. Questions: Contact your Siemens Customer Care Center or your local Siemens technical support representative
Quantity in Commerce 159 units
Distribution Nationwide Foreign: Australia Bangladesh Chile Colombia France Germany Hong Kong India Ireland Japan Latvia Mexico Spain Switzerland Thailand Uruguay
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CHL and Original Applicant = BAYER HEALTHCARE, LLC
510(K)s with Product Code = CHL and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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