Recall Z-0165-2026 · DPS Electrocardiograph
Philips North America
Cardiac Workstation 5000; Model Number: 860439;
| Date | Oct 16, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 no |
| Quantity | 28 units |
| Distribution | US Nationwide distribution in the states of CA, IA, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) Philips Medizin Systeme Böblingen GmbH, Dec 17, 2024 |