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

SmartPath to dStream for 1.5T¿; Product Number recalled

Philips North America is recalling SmartPath to dStream for 1.5T¿; Product Number: 782146, 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: 782146; UDI-DI: no UDI; Serial Number: 13013;

Quantity recalled1 unit

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-1936-2025
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: Device Malfunction
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.

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

SmartPath to dStream for 1.5T¿; Product Number: 782146;

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

Why was it recalled?

Which lots are affected?

Product Number: 782146; UDI-DI: no UDI; Serial Number: 13013;

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 96999

This product is part of a recall event; the main page for the event is Intera 1.5T Achieva Nova-Dual Product Number recalled.

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025	CLASS II	Intera 1.5T Achieva Nova-Dual Product Number recalled	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Intera 1.5T Explorer/Nova Dual Product Number recalled	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Intera 1.5T Achieva IT Nova Product Number recalled	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Intera 1.5T Achieva Nova Product Number recalled	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Intera Achieva 1.5T Pulsar recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Intera 1.5T Master/Nova Product Number recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Intera 1.5T Omni/Stellar recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
18 Jun 2025	CLASS II	Achieva XR Product Numbers recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

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