FDA-Device2025-10-22Class II

Cardiac Workstation 5000; Model Number: 860439;

Hazard

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

Sold states
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Affected count
28 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Cardiac Workstation 5000; Model Number: 860439;

Official notice

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

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