CLASS II ONGOING Device recall · Reported 28 May 2025 · FDA Enforcement Report

SmartPath to dStream for 5T recalled by Philips North America

Philips North America is recalling SmartPath to dStream for 5T, distributed nationwide in the US. The recall was initiated on 13 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: (1) 781260, (2) 782112, (3) 782146; UDI-DI: (1) 00884838095076,(2) 00884838098886, (3) 00884838108691; Serial Numbers: (1) 10044, 10151, 10164, 10170, 11000, 11001, 11062, 11076, 12009, 18038, 18663, 18872, 18938, 20115, 20164, 20413, 21011, 21019, 21062, 21133, 21249, 21278, 21477, 21577, 21583, 21591, 21880, 21888, 22157, 22248, 32049, 32094, 32099, 32113, 32142, 32184, 32217, 32245, 32286, 32322, 32334, 32636, 32845, 39024, 5479, 5490, 8057, 8263, 8305, 8330, 8365, 8378, 8392, 8456, 8561, 8639, 8736, 8752, 8808, 8819, 8942, (2) 10479, 12002, 13024, 18651, 21205, 21685, 22267, 30031, 39106, (3) 13013, 20414, 21202, 21990, 22251, 32116, 32407, 32683, 33611, 39040;

Quantity recalled80 units (1 US, 79 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-1788-2025
FDA event ID: 96889
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 13 May 2025
FDA classified: 16 May 2025
Reported: 28 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 May 2025	Recall initiated by company
16 May 2025	Classified by FDA	+3 days
28 May 2025	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

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Product as listed by the FDA

Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.

Nationwide Georgia

Questions about this recall

Is SmartPath to dStream for 5T recalled?

Yes. Philips North America recalled SmartPath to dStream for 5T on 13 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-1788-2025.

Why was it recalled?

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Which lots are affected?

Model Numbers: (1) 781260, (2) 782112, (3) 782146; UDI-DI: (1) 00884838095076,(2) 00884838098886, (3) 00884838108691; Serial Numbers: (1) 10044, 10151, 10164, 10170, 11000, 11001, 11062, 11076, 12009, 18038, 18663, 18872, 18938, 20115, 20164, 20413, 21011, 21019, 21062, 21133, 21249, 21278, 21477, 21577, 21583, 21591, 21880, 21888, 22157, 22248, 32049, 32094, 32099, 32113, 32142, 32184, 32217, 32245, 32286, 32322, 32334, 32636, 32845, 39024, 5479, 5490, 8057, 8263, 8305, 8330, 8365, 8378, 8392, 8456, 8561, 8639, 8736, 8752, 8808, 8819, 8942, (2) 10479, 12002, 13024, 18651, 21205, 21685, 22267, 30031, 39106, (3) 13013, 20414, 21202, 21990, 22251, 32116, 32407, 32683, 33611, 39040;

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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