Cardiac Workstation 7000; Model Number: 860441;
- Company
- Philips North America
- Recall Initiated
- September 12, 2025
- Posted
- October 16, 2025
- Recall Number
- Z-0166-2026
- Quantity
- 29 units
- Firm Location
- Cambridge, MA
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.
Lot / Code Info
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
Root Cause
Process control
Action Taken
On September 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Share this communication with all clinical staff to review and undedrstand. Please this letter with the device. Pass the notice along to all those who need to be aware within the organization or to any organization where affected devices were transferred. Ensure technical solution established by Philips is implemented as soon as available within the timeframe communicated by Philips. In case any device cannot be corrected, inform Philips of the reason why the Technical Solution could not be implemented. Action By Philips: A Philips representative will contact customers to arrange a replacement of the device's hardware on affected devices with the pinched power module wire within the housing of the Cardiac Workstation.