FDA Enforcement
Class II
Ongoing
Cardiac Workstation 7000; Model Number: 860441;
Recall: Z-0166-2026
·
Reported October 22, 2025
Enforcement
- Recall Number
- Z-0166-2026
- Event ID
- 97612
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 22, 2025
- Initiation Date
- September 12, 2025
- Classification Date
- October 16, 2025
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2296, United States
Description
Cardiac Workstation 7000; Model Number: 860441;
Reason
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Code Info
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
Distribution
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Quantity
29 units