CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

DigitalDiagnost 4 High Performance, Flex/Value recalled

Philips Medical Systems DMC is recalling DigitalDiagnost 4 High Performance, Flex/Value, distributed nationwide in the US. The recall was initiated on 1 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, SN16000022, SN20000013; 2. Model Number: 712032; UDI-DI: 00884838074514; Serial Numbers: 10001179, 19000341, 19000342, 19000343;

Quantity recalled12 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-0464-2026
FDA event ID: 97748
Recalling firm: Philips Medical Systems DMC, Hamburg
Classification: Class II
Status: Ongoing
Recall initiated: 1 Oct 2025
FDA classified: 7 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Oct 2025	Recall initiated by company
7 Nov 2025	Classified by FDA	+37 days
19 Nov 2025	Published in enforcement report	+12 days

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

Reason for recall

Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

Product as listed by the FDA

DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;

Where it was distributed

Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland, France, Germany, Ghana, Gibraltar, Guadeloupe, Indonesia, Iraq, Israel, Italy, Jordan, Kuwait, Kyrgyzstan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Samoa, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, T¿rkiye, Turkmenistan, United Kingdom, Utd.Arab.Emir.,

Nationwide

Questions about this recall

Is DigitalDiagnost 4 High Performance, Flex/Value recalled?

Yes. Philips Medical Systems DMC recalled DigitalDiagnost 4 High Performance, Flex/Value on 1 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0464-2026.

Why was it recalled?

Which lots are affected?

1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, SN16000022, SN20000013; 2. Model Number: 712032; UDI-DI: 00884838074514; Serial Numbers: 10001179, 19000341, 19000342, 19000343;

Where was it sold?

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

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