CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report

Intera 5T Omni/Stellar recalled by Philips Medical Systems

Philips Medical Systems Nederlands is recalling Intera 5T Omni/Stellar, distributed nationwide in the US. The recall was initiated on 21 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll systems

Quantity recalled11226 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-0877-2019
FDA event ID: 82038
Recalling firm: Philips Medical Systems Nederlands, Best
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2018
FDA classified: 22 Feb 2019
Reported: 6 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

21 Dec 2018	Recall initiated by company
22 Feb 2019	Classified by FDA	+63 days
6 Mar 2019	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

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Product as listed by the FDA

Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System

Where it was distributed

U.S. Nationwide distribution.

Nationwide

Questions about this recall

Is Intera 5T Omni/Stellar recalled?

Yes. Philips Medical Systems Nederlands recalled Intera 5T Omni/Stellar on 21 Dec 2018. The recall is Class II and its status is Terminated. Recall number Z-0877-2019.

Why was it recalled?

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Which lots are affected?

All systems

Where was it sold?

U.S. Nationwide distribution.

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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