Company:Fresenius Medical Care Renal Therapies Group, LLC
Date of Enforcement Report 3/7/2018
Class lI:
PRODUCT
Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Recall Number Z-0829-2018
REASON
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.
RECALLING FIRM/MANUFACTURER
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA on 10/5/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15 machines
DISTRIBUTION
Nationwide
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