Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RAPIDPoint 500e Blood Gas Systems

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall RAPIDPoint 500e Blood Gas Systems see related information
Date Initiated by Firm May 27, 2020
Create Date June 26, 2020
Recall Status1 Terminated 3 on January 12, 2021
Recall Number Z-2432-2020
Recall Event ID 85750
510(K)Number K192240  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Code Information All units
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information Contact Meiping Shen
339-206-9989
Manufacturer Reason
for Recall		 The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes.
FDA Determined
Cause 2		 Software design
Action On May 27, 2020, the firm notified customers via Urgent Field Safety Notice letters. Product was distributed to foreign customers only. Customers were instructed to complete and return the included customer response form. Customers whose systems are not configured to use code 39 with check-digit need take no further action. However, for customers whose systems are configured to use code 39 with check-digit, the customer notice provided two workaround options: 1) Use the integrated on-board barcode scanner, or 2) Re-configure the handheld barcode scanner following the instructions in the letter. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative
Quantity in Commerce 436
Distribution Foreign distribution only.
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 = Siemens Healthcare Diagnostics, Inc.
-
-