FDA recall Z-0829-2018

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

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

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