| Class 2 Device Recall Atellica Solution | |
Date Initiated by Firm | September 26, 2018 |
Create Date | January 29, 2019 |
Recall Status1 |
Terminated 3 on June 24, 2020 |
Recall Number | Z-0783-2019 |
Recall Event ID |
81380 |
510(K)Number | K161954 |
Product Classification |
Calibrator, secondary - Product Code JIT
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Product | Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. |
Code Information |
Software in V 1.14.2 and lower. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact | SAME 914-631-8000 |
Manufacturer Reason for Recall | Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300 Analyzer
Atellica IM 1600 Analyzer;Atellica CH 930 Analyzer;
Atellica Sample Handler Prime
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FDA Determined Cause 2 | Software design |
Action | Siemens Healthcare Diagnsotics issue an Urgent Medical Device Correction (UMDC) was issued to US customers via Fed-Ex on September 26, 2018. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens sites with affected customers electronically for distribution and regional reporting to their local competent authorities. The letter explains the reasons, observed behaviors, risk to health, actions to be taken. Review the letter with the Medical Director. "
Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. The system will be updated with software version- SW V1.15 which resolves issues. |
Quantity in Commerce | 410 units |
Distribution | Worldwide distributions - US Nationwide and countries of
Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia
Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Poland, Portugal, Republic Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand,
Turkey, U.A.E., United Kingdom, Vietnam. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JIT
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