# FDA recall Z-0829-2018

> **Fresenius Medical Care Renal Therapies Group, LLC** · Class II · device recall initiated 2017-10-05.

## Product

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

## 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

## Key facts

- **Recall number:** Z-0829-2018
- **Recalling firm:** Fresenius Medical Care Renal Therapies Group, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-05
- **Report date:** 2018-03-07
- **Termination date:** 2021-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0829-2018

## Citation

> AI Analytics. FDA recall Z-0829-2018. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0829-2018. Source: US FDA. Licensed CC0.

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