CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

Philips Zenition 50, System recalled by Philips North America

Philips North America is recalling Philips Zenition 50, System, distributed nationwide in the US. The recall was initiated on 10 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 17 7

Quantity recalled25 total

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-1932-2020
FDA event ID: 85473
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Apr 2020
FDA classified: 8 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

10 Apr 2020	Recall initiated by company
8 May 2020	Classified by FDA	+28 days
20 May 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

When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

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 Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of MD and MI. The countries of Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.

Nationwide Maryland Michigan

Questions about this recall

Is Philips Zenition 50, System recalled?

Yes. Philips North America recalled Philips Zenition 50, System on 10 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1932-2020.

Why was it recalled?

Which lots are affected?

Serial Numbers 17 7

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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