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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius 2008T Hemodialysis Machine: OLC/DIASAFE plus, w CDX, wBIBAG, GEN 2 BGEN 2 BIBAG w/o CDX

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  Class 2 Device Recall Fresenius 2008T Hemodialysis Machine: OLC/DIASAFE plus, w CDX, wBIBAG, GEN 2 BGEN 2 BIBAG w/o CDX see related information
Date Initiated by Firm March 12, 2020
Create Date April 20, 2020
Recall Status1 Open3, Classified
Recall Number Z-1748-2020
Recall Event ID 85310
510(K)Number K173972  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Fresenius 2008T Hemodialysis Machine:
Part Number Description
190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS;
190713 2008T HEMODIAL YSIS SYS., with CDX;
190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG;
190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX;
190895 2008T GEN 2 BIBAG WITHOUT CDX;
190908 2008T HD System With CDX, CAN
Code Information All serial numbers
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		 A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine
FDA Determined
Cause 2		 Software design
Action Fresenius Medical Care issued via First Class Mail on 03-12-2020 Important Medical Device Correction Customer Notification explaining the issue, health risk and action to take: To clear the alarm, tum the machine power off for 30 to 45 seconds and turn back on. If the alarm has not been cleared, repeat the power off cycle again. If still not cleared, perform a manual blood return and remove the patient from the machine. Remove the machine from service and contact a qualified service technician. This alarm may reoccur even after a power cycle has been performed. true alarm will only occur when an externally powered USB device is connected. Refer to the Operators Manual Troubleshooting section for instructions. A Reply Form included for confirmation the consignee read and understands the notice sent to them and ask for number of machines corrected. A software solution is being created that addresses this situation. Once the software upgrade is available, an additional notification will be sent with instructions on how to order the upgrade at no charge. If you experience this issue or have additional questions, please contact Fresenius Medical Care Technical Services at 800-227-2572
Quantity in Commerce 101,463
Distribution Nationwide Foreign: Canada, Curaca, Guam
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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