Cardiac Workstation recallZ-0165-2026 · Philips North America · initiated Sep 12, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0165-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 12, 2025
- Posted by the FDA
- Oct 16, 2025
- Recalling firm
- Philips North America
- Quantity
- 28 units
- Product code
- DPS
- FDA submissions
- K241556
- Distribution
- US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Product description
Cardiac Workstation 5000; Model Number: 860439;
Code information (models, lots, serial numbers)
Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cardiac Workstation Cardiac Workstation 5000Philips Medizin Systeme Böblingen GmbH · Electrocardiograph2 recalls1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97612).
- Z-0166-2026 · Open, ClassifiedCardiac Workstation 7000; Model Number: 860441;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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