CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report

Cardiac Workstation recalled by Philips North America

Philips North America is recalling Cardiac Workstation 5000, distributed nationwide in the US. The recall was initiated on 12 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 860439; UDI-DI: 00884838094826; Serial Numbers:

Quantity recalled28 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0165-2026
FDA event ID: 97612
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Sep 2025
FDA classified: 16 Oct 2025
Reported: 22 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Sep 2025	Recall initiated by company
16 Oct 2025	Classified by FDA	+34 days
22 Oct 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Cardiac Workstation 5000; Model Number: 860439;

Where it was distributed

US Nationwide distribution in the states of CA, IA, TN, TX, VA.

Nationwide California Iowa Tennessee Texas Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:

Where was it sold?

US Nationwide distribution in the states of CA, IA, TN, TX, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97612

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025	CLASS II	Cardiac Workstation recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

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