CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report

Philips DXR System, DuraDiagnost recalled by Philips North America

Philips North America is recalling Philips DXR System, DuraDiagnost 1, distributed nationwide in the US. The recall was initiated on 10 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.

Quantity recalled83 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-1553-2025
FDA event ID: 96435
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Mar 2025
FDA classified: 11 Apr 2025
Reported: 23 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

10 Mar 2025	Recall initiated by company
11 Apr 2025	Classified by FDA	+32 days
23 Apr 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

Potential for collimator to fall as a result of incorrect installation.

Product as listed by the FDA

Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

Where it was distributed

Worldwide - US Nationwide distribution in the states of AK, FL, KS, MS, NH, NY, OR, PA, TX, WI and the countries of Argentina, Australia, Canada, Chile, China, Germany, Hungary, India, Indonesia, Italy, Kenya, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Poland, Romania, Russian Federation, Slovenia, South Africa, Spain, Thailand, United Kingdom, Vietnam.

Nationwide Alaska Florida Kansas Mississippi New Hampshire New York Oregon Pennsylvania Texas Wisconsin

Questions about this recall

Is Philips DXR System, DuraDiagnost 1 recalled?

Yes. Philips North America recalled Philips DXR System, DuraDiagnost 1 on 10 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1553-2025.

Why was it recalled?

Potential for collimator to fall as a result of incorrect installation.

Which lots are affected?

REF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.

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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