CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report

UroDiagnost Eleva, system recalled by Philips North America

Philips North America is recalling UroDiagnost Eleva, system, distributed nationwide in the US. The recall was initiated on 30 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers 64 48 2 60

Quantity recalled4

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-1492-2020
FDA event ID: 84756
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 30 Dec 2019
FDA classified: 13 Mar 2020
Reported: 25 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Dec 2019	Recall initiated by company
13 Mar 2020	Classified by FDA	+74 days
25 Mar 2020	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

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

Product as listed by the FDA

UroDiagnost Eleva, system code 708033

Where it was distributed

Nationwide domestic distribution. Foreign distribution worldwide.

Nationwide

Questions about this recall

Is UroDiagnost Eleva, system recalled?

Yes. Philips North America recalled UroDiagnost Eleva, system on 30 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1492-2020.

Why was it recalled?

A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

Which lots are affected?

Serial numbers 64 48 2 60

Where was it sold?

Nationwide domestic distribution. Foreign distribution worldwide.

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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