CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report

DuraDiagnost stationary X-ray system recalled by Philips Healthcare

Philips Healthcare is recalling DuraDiagnost stationary X-ray system, distributed nationwide in the US. The recall was initiated on 10 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codessoftware version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

Quantity recalled5

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-1696-2016
FDA event ID: 74083
Recalling firm: Philips Healthcare, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Nov 2015
FDA classified: 3 Jun 2016
Reported: 15 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

10 Nov 2015	Recall initiated by company
3 Jun 2016	Classified by FDA	+206 days
15 Jun 2016	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

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

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

Philips Healthcare DuraDiagnost stationary X-ray system

Where it was distributed

USA (nationwide) Distribution to the states of : ( DuraDiagnost) to the states of : OH, CA, WA and NE. (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.

Nationwide Alaska Alabama Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Kentucky Louisiana Massachusetts Maryland Maine Minnesota Missouri Mississippi North Dakota

Questions about this recall

Why was it recalled?

The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image.

Which lots are affected?

software version - 4.0.2, 4.0.3, 4.0.4 into 4.0.5

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 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 74083

This product is part of a recall event; the main page for the event is DigitalDiagnost stationary X-ray system recalled by Philips Healthcare.

Reported	Class	Recall	Company	Reason	Where
15 Jun 2016	CLASS II	DigitalDiagnost stationary X-ray system recalled by Philips Healthcare	Philips Healthcare	Device Malfunction	Nationwide

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