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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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  Class 2 Device Recall Siemens see related information
Date Initiated by Firm May 15, 2020
Create Date June 29, 2020
Recall Status1 Terminated 3 on August 12, 2022
Recall Number Z-2470-2020
Recall Event ID 85731
510(K)Number K970227  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
Code Information Serial numbers A001 through M5295
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc.
62 Flanders-Bartley Rd.
Flanders NJ 07836-4715
For Additional Information Contact SAME
914-524-2619
Manufacturer Reason
for Recall		 Flexible tubing connected to the liquid waste bottle can crack during routine customer maintenance potentially causing liquid waste can leak onto the floor, creating a slip and fall hazard
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens issued an Urgent Medical Device Correction (UMDC IMI20-01.A.US) to US customers via FedEx on May 15, 2020. Urgent Field Safety Notice (UFSN IMI20-01.A.OUS) 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 May 15, 2020. The field action letters explain the issue, health risk and and inform customers of actions to take: Siemens Customer Service Engineers shall be visiting customer sites to replace Waste Bottle Flex Tubing Assemblies. Customers are requested to return the Effectiveness Check Form, in the UMDC/UFSN via fax or email.
Quantity in Commerce 2925 units
Distribution Worldwide distribution - US Nationwide distribution and the countries of AE, AO, AR, AT, AU, AZ, BA, BD, BE, BG, BH, BO, BR, BS, BY, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GP, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KR, KW, KZ, LB, LT, LU, LV, LY, ME, MK, MM, MQ, MT, MU, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, SY, TH, TN, TR, TT, TW, UA, UY, VE VN, ZA.
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 = DPC CIRRUS
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