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U.S. Department of Health and Human Services

Class 2 Device Recall 2008T Hemodialysis Delivery System

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  Class 2 Device Recall 2008T Hemodialysis Delivery System see related information
Date Initiated by Firm October 05, 2017
Date Posted February 20, 2018
Recall Status1 Terminated 3 on July 28, 2021
Recall Number Z-0829-2018
Recall Event ID 79239
510(K)Number K121341  K120505  K080964  K120017  K113427  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product 2008T, Hemodialysis Delivery System

Product Indicated for acute and chronic dialysis therapy.
Code Information 2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX  190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact Beth St.Germain
781-699-2243
Manufacturer Reason
for Recall		 While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
FDA Determined
Cause 2		 Software Design Change
Action Fresenius Medical Care sent an Urgent Medical Device Correction letter dated April 24, 2017 to affected customers. the letter identified the affected product, problem and actions to be taken. For questions contact Technical Services at 1-800-227-2572.
Quantity in Commerce 15 machines
Distribution US Nationwide Distribution
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 = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE, NORTH AMERICA
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