Fresenius Medical Care Renal Therapies Group, LLC: 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

Is my product affected?

2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.

• UPC 00840861100910
• UPC 00840861100927

Check against the official notice below — it lists the full affected range.

What happened

Fresenius Medical Care is recalling 15 of its 2008T Hemodialysis Delivery Systems distributed nationwide. The systems have a software problem: when the ultrafiltration (UF) goal is set to '0,' there is a mismatch between the UF rate shown on the display and the actual UF pump rate. The issue affects 2008T machines that contain the 2.63 Bug Fix, 2008T Upgrade kits with the 2.63 Bug Fix, and software version 2.64.

The specific affected units are identified by model numbers 190766 and 190895, with corresponding UPC codes and serial numbers. According to the recall record, no remedy has been specified for this issue.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: US Nationwide Distribution Quantity: 15 machines Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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