Cardiac Workstation 5000; Model Number: 860439;
FDA device recall Z-0165-2026 · posted 2025-10-16 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 28 units
- Distribution
- US Nationwide distribution in the states of CA, IA, TN, TX, VA.
- Date initiated
- 2025-09-12
- Date posted
- 2025-10-16
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cardiac Workstation (5000); Cardiac Workstation (7000) (K241556) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |