Z-0165-2026Class II

Cardiac Workstation 5000; Model Number: 860439

Name: Z-0165-2026 Cardiac Workstation 5000; Model Number: 860439
Creator: Philips North America
Published: 2025-09-12
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2025-09-12 / Open, Classified / root cause: manufacturing process

FDA source

Philips North America began a recall of Cardiac Workstation 5000; Model Number: 860439 on 2025-09-12. FDA classified it as Class II and gives the reason as "Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0165-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-12
Posted: 2025-10-16
Recalling firm: Philips North America LLC
Product: Cardiac Workstation 5000; Model Number: 860439;
Product code: DPS Electrocardiograph
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 28 units
Distribution: US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Product codes and lots: Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0165-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0165-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0166-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code DPS

K241556Class IICardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH / cleared 2024-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)