CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report

Intera 5T Master/Nova Product Number recalled by Philips North America

Philips North America is recalling Intera 5T Master/Nova Product Number: 781106, distributed nationwide in the US. The recall was initiated on 29 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number: 781106; UDI-DI: no UDI; Serial Numbers: 8009, 18863;

Quantity recalled2 units (US only)

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-1933-2025
FDA event ID: 96999
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 29 May 2025
FDA classified: 9 Jun 2025
Reported: 18 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Other Medical Devices

Timeline

29 May 2025	Recall initiated by company
9 Jun 2025	Classified by FDA	+11 days
18 Jun 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Intera 1.5T Master/Nova Product Number: 781106;

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.

Nationwide Arizona California Delaware Massachusetts Michigan Nebraska New York South Dakota

Questions about this recall

Is Intera 5T Master/Nova Product Number: 781106 recalled?

Yes. Philips North America recalled Intera 5T Master/Nova Product Number: 781106 on 29 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-1933-2025.

Why was it recalled?

Which lots are affected?

Product Number: 781106; UDI-DI: no UDI; Serial Numbers: 8009, 18863;

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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