CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report

SmartPath to dStream for 5T recalled by Philips Medical Systems

Philips Medical Systems Nederland B.v is recalling SmartPath to dStream for 5T, distributed nationwide in the US. The recall was initiated on 24 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number (REF): 782146; UDI-DI: N/A; All serial numbers.

Quantity recalled3 units 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-1782-2025
FDA event ID: 96728
Recalling firm: Philips Medical Systems Nederland B.v, Best
Classification: Class II
Status: Ongoing
Recall initiated: 24 Mar 2025
FDA classified: 15 May 2025
Reported: 21 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

24 Mar 2025	Recall initiated by company
15 May 2025	Classified by FDA	+52 days
21 May 2025	Published in enforcement report	+6 days

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

Reason for recall

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

SmartPath to dStream for 1.5T, Model Number: 782146;

Where it was distributed

US: Nationwide Distribution International: Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.

Nationwide Georgia

Questions about this recall

Is SmartPath to dStream for 5T recalled?

Yes. Philips Medical Systems Nederland B.v recalled SmartPath to dStream for 5T on 24 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1782-2025.

Why was it recalled?

Which lots are affected?

Model Number (REF): 782146; UDI-DI: N/A; All serial numbers.

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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