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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Atellica CH 930 Analyzer

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 Class 2 Device Recall Siemens Atellica CH 930 Analyzersee related information
Date Initiated by FirmJuly 30, 2019
Create DateOctober 16, 2019
Recall Status1 Terminated 3 on June 10, 2022
Recall NumberZ-0148-2020
Recall Event ID 83529
510(K)NumberK151767 
Product Classification Electrode, ion specific, sodium - Product Code JGS
ProductSiemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Code Information Software version: V1.19.2 and below
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactSAME
914-631-8000
Manufacturer Reason
for Recall		Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
FDA Determined
Cause 2		Software design
ActionSiemens issued an Urgent medical Device Correction, (UMDC ASI19-02.A.US) via Fed Ex and Urgent Field Safety Notification (UFSN ASI19-02.A.OUS) to all affected Customers beginning on 2019-07-30. The UFSN/UMDC explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email within 30 days. Field Service personnel will be sent a Service Knowledge Base describing the issue and instructing them how to deal with customer questions.
Quantity in Commerce1125 units
DistributionWorldwide Distribution - US Nationwide Foreign: Argentina Australia Austria Bangladesh Belgium Brazil Bulgaria Canada Chile Colombia Czech Republic Denmark Ecuador Egypt Finland France Germany Greece Hungary India Indonesia Iran Ireland Israel Italy Japan Kuwait Latvia Malaysia Mexico Netherlands Nigeria Norway P.R. China Pakistan Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom 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 = JGS
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