CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report

Sonalleve MR HIFU 0T - Magnetic Resonance recalled

Philips North America is recalling Sonalleve MR HIFU 0T - Magnetic Resonance (MR) systems are Medical Electrical Systems, distributed nationwide in the US. The recall was initiated on 3 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: N/A Serial Number: 6102 6115 6101 34007

Quantity recalled4 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-1864-2024
FDA event ID: 94508
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 3 May 2024
FDA classified: 17 May 2024
Reported: 29 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

3 May 2024	Recall initiated by company
17 May 2024	Classified by FDA	+14 days
29 May 2024	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 g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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

Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

Nationwide

Questions about this recall

Is Sonalleve MR HIFU 0T - Magnetic Resonance (MR) systems are Medical Electrical Systems recalled?

Yes. Philips North America recalled Sonalleve MR HIFU 0T - Magnetic Resonance (MR) systems are Medical Electrical Systems on 3 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-1864-2024.

Why was it recalled?

Which lots are affected?

UDI-DI: N/A Serial Number: 6102 6115 6101 34007

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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