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U.S. Department of Health and Human Services

Class 2 Device Recall Refrigerated Storage Module (RSM), Centrifuge Module (CM) and i2000SR Interface Modules (i2000SR).

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  Class 2 Device Recall Refrigerated Storage Module (RSM), Centrifuge Module (CM) and i2000SR Interface Modules (i2000SR). see related information
Date Initiated by Firm September 29, 2016
Create Date November 16, 2016
Recall Status1 Terminated 3 on September 19, 2018
Recall Number Z-0590-2017
Recall Event ID 75417
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Aptio Automation Modules
Code Information "Refrigerated Storage Module (RSM): 10703049, 10715227, 10703036, 10713762, 10713767; "Centrifuge Module (CM): 10703032, 10713761, 10713764; "i2000SR Interface Module (i2000SR): 10989303, 10989304. 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer Reason
for Recall		 Possible overheating of power cord plugs used to connect to FlexLab and Aptio Automation systems.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens mailed to customers an Urgent Field Safety Notification letter warning them of the problem and to inform them that Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.
Quantity in Commerce 448 units
Distribution Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., 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.
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