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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm July 27, 2022
Date Posted December 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0734-2023
Recall Event ID 91154
510(K)Number K173972  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility
Models:
(1) 190713 2008T HEMODIALYSIS SYS., with CDX;
(2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ;
(3) 191124 2008T HD SYS. CDX BLUESTAR;
(4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
Code Information Software issue in SW versions 2.72 and earlier with CDX. UDI: (1) 00840861100897; (2) 00840861100910; (3) 00840861102082; (4) 00840861102099
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information Contact SAME
781-6999580
Manufacturer Reason
for Recall		 (1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".
FDA Determined
Cause 2		 Process design
Action Fresenius issued Updated Urgent Medical Device Correction REV B Customer Notification letter (Field Action Number: FA-2020-09-W _REV B) to consignees that have CDX equipped machines on 07-27-2022 via USPS First Class Mail. Letter states reason for recall, health risk and action to take: First, a software issue in SW versions 2.72 and earlier. All machines should be updated to current software (SW version 2.74), pursuant to the July 20, 2021, letter. Second, hardware issue that affects only CDX machines. To reduce the chance of EMI causing a false Remove USB Device 2 alarm from occurring we suggest the following: " Insert a USB device in USB Port 2 that will continually draw current. For example, a blank USB memory stick or a USB powered card reader. o NOTE: DO NOT use passive USB devices in USB Port 2 that go into a suspended state drawing minimal/low current which can trip the sensing circuit. An example would be a USB corded optical mouse. Complete/Return the response form enclosed.
Quantity in Commerce 2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KDI and Original Applicant = Fresenius Medical Care Renal Therapies Group, LLC
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