Date Initiated by Firm |
August 15, 2019 |
Create Date |
October 24, 2019 |
Recall Status1 |
Terminated 3 on May 05, 2022 |
Recall Number |
Z-0204-2020 |
Recall Event ID |
83655 |
510(K)Number |
K151792
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001 |
Code Information |
(SW) version V1.19.0 and V1.19.2 UDI: 00630414007960 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact |
SAME 914-631-8000
|
Manufacturer Reason for Recall |
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer
SW V 1.19.0 and 1.19.2
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens issued an Urgent Medical Device Correction (UMDC) to US customers via FedEx on August 15, 2019. The UFSN was electronically issued to all OUS Siemens sites, with affected customers, for distribution, as well as regional reporting to their respective local competent authority on August 16, 2019.
The UMDC/UFSN explain the behavior(s) to users and provide actions to be taken to correct the behavior. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email.
Siemens Healthcare Diagnostics Inc. has released an updated software (SW) version (V) 1.20.0, which corrects the reported behavior(s). A Mandatory Update (MU) campaign has been launched to install the new SW V on all systems, whether or not they are impacted by these behaviors. |
Quantity in Commerce |
88 total US: 54;OUS 34 |
Distribution |
Nationwide
Foreign:
Argentina
Australia
Bangladesh
Belgium
Brazil
Colombia
Dominican Republic
Finland
France
Germany
Greece
Italy
Japan
Latvia
Mexico
Netherlands
P.R. China
Republic Korea
Singapore
Spain
Switzerland
Thailand
United Kingdom
Vietnam |
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 = JJE and Original Applicant = Siemens Healthcare Diagnostics,Inc.
|