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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens RAPEDPoint500

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  Class 3 Device Recall Siemens RAPEDPoint500 see related information
Date Initiated by Firm July 05, 2016
Date Posted August 19, 2016
Recall Status1 Terminated 3 on August 02, 2017
Recall Number Z-2601-2016
Recall Event ID 74564
510(K)Number K113216  
Product Classification Acid, lactic, enzymatic method - Product Code KHP
Product Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A
The RAPIDPoint 500 system is designed 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. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili
Code Information Software Version 2.2A
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
Manufacturer Reason
for Recall		 Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens sent a Customer Notification dated July 2016 to all affected domestic (US) customers via Federal Express on July 5, 2016. Customers were asked to take the following actions: Please do not use the dialysate mode. If you have enabled this feature, please disable it by following these instructions: 1. At the System screen, select Setup. 2. Select Secured Options > Analysis Options. 3. Unselect Dialysate. 4. Select the Continue button 3 times. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check attached to this letter within 7 days. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens Technical Support representative. For questions regarding this recall call 781-269-3000.
Quantity in Commerce 76
Distribution Nationwide Distribution to AL, CA, MA, NJ, OH, TX, WA, PA
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 = KHP and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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