Z-0166-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
Product Description
Cardiac Workstation 7000; Model Number: 860441;
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 Pattern
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Code Information
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;