FDA recall Z-0165-2026

Product

Cardiac Workstation 5000; Model Number: 860439;

Reason for recall

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

Distribution

US Nationwide distribution in the states of CA, IA, TN, TX, VA.

Key facts

Status

Ongoing

Initiation date

2025-09-12

Report date

2025-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0165-2026