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

Intera Achieva 1.5T Pulsar recalled by Philips North America

Philips North America is recalling Intera Achieva 1.5T Pulsar, 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: 781171; UDI-DI: no UDI; Serial Numbers: 11044, 11039, 18627, 11069;

Quantity recalled4 units (1 US, 3 OUS)

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-1935-2025
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

Intera Achieva 1.5T Pulsar; Product Number: 781171;

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: 781171; UDI-DI: no UDI; Serial Numbers: 11044, 11039, 18627, 11069;

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	SmartPath to dStream for 1.5T¿; 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 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

More recalls from Philips North America

All 558

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide