CLASS II ONGOING Device recall · Reported 29 Nov 2023 · 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 23 Oct 2023 and the FDA has classified it as Class II.
Check your package
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-0395-2024
- FDA event ID
- 93361
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2023
- FDA classified
- 21 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2023 | Recall initiated by company | |
| 21 Nov 2023 | Classified by FDA | +29 days |
| 29 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential component failure in the Gradient Coil could product smoke and/or fire.
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
Where it was distributed
Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
Questions about this recall
Is SmartPath to dStream for 5T recalled?
Yes. Philips North America recalled SmartPath to dStream for 5T on 23 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0395-2024.
Why was it recalled?
Potential component failure in the Gradient Coil could product smoke and/or fire.
Which lots are affected?
Product No. 781260 & 782112; UDI-DI: (01)00884838095076(21)5447, (01)00884838095076(21)5463, (01)00884838095076(21)5479, (01)00884838095076(21)5490, (01)00884838095076(21)5537, (01)00884838095076(21)5546, (01)00884838095076(21)8012, (01)00884838095076(21)8025, (01)00884838095076(21)8054, (01)00884838095076(21)8086, (01)00884838095076(21)8087, (01)00884838095076(21)8091, (01)00884838095076(21)8092, (01)00884838095076(21)8110, (01)00884838095076(21)8118, (01)00884838095076(21)8178, (01)00884838095076(21)8260, (01)00884838095076(21)8311, (01)00884838095076(21)8318, (01)00884838095076(21)8365, (01)00884838095076(21)8378, (01)00884838095076(21)8387, (01)00884838095076(21)8392, (01)00884838095076(21)8395, (01)00884838095076(21)8427, (01)00884838095076(21)8554, (01)00884838095076(21)8566, (01)00884838095076(21)8578, (01)00884838095076(21)8611, (01)00884838095076(21)8616, (01)00884838095076(21)8639, (01)00884838095076(21)8642, (01)00884838095076(21)8667, (01)00884838095076(21)8706, (01)00884838095076(21)8713, (01)00884838095076(21)8746, (01)00884838095076(21)8750, (01)00884838095076(21)8752, (01)00884838095076(21)8779, (01)00884838095076(21)8783, (01)00884838095076(21)8786, (01)00884838095076(21)8831, (01)00884838095076(21)8840, (01)00884838095076(21)8851, (01)00884838095076(21)8857, (01)00884838095076(21)8884, (01)00884838095076(21)8895, (01)00884838095076(21)8896, (01)00884838095076(21)8923, (01)00884838095076(21)8942, (01)00884838095076(21)8948, (01)00884838095076(21)9004, (01)00884838095076(21)9013, (01)00884838095076(21)10029, (01)00884838095076(21)10044, (01)00884838095076(21)10075, (01)00884838095076(21)10079, (01)00884838095076(21)10130, (01)00884838095076(21)10151, (01)00884838095076(21)10164, (01)00884838095076(21)10170, (01)00884838095076(21)10174, (01)00884838095076(21)10185, (01)00884838095076(21)10191, (01)00884838095076(21)10458, (01)00884838095076(21)10511, (01)00884838095076(21)10513, (01)00884838095076(21)10554, (01)00884838095076(21)10906, (01)00884838095076(21)10915, (01)00884838095076(21)11031, (01)00884838095076(21)11047, (01)00884838095076(21)11062, (01)00884838095076(21)11076, (01)00884838095076(21)11085, (01)00884838095076(21)11091, (01)00884838095076(21)11102, (01)00884838095076(21)12030, (01)00884838095076(21)13011, (01)00884838095076(21)13029, (01)00884838095076(21)13032, (01)00884838095076(21)13062, (01)00884838095076(21)18038, (01)00884838095076(21)18670, (01)00884838095076(21)18761, (01)00884838095076(21)18957, (01)00884838095076(21)20071, (01)00884838095076(21)20111, (01)00884838095076(21)20226, (01)00884838095076(21)21062, (01)00884838095076(21)21213, (01)00884838095076(21)21576, (01)00884838095076(21)21582, (01)00884838095076(21)21801, (01)00884838095076(21)21814, (01)00884838095076(21)22013, (01)00884838095076(21)22017, (01)00884838095076(21)22031, (01)00884838095076(21)22086, (01)00884838095076(21)22098, (01)00884838095076(21)22102, (01)00884838095076(21)22144, (01)00884838095076(21)22157, (01)00884838095076(21)22248, (01)00884838095076(21)30033, (01)00884838095076(21)32218, (01)00884838095076(21)33044, (01)00884838095076(21)33246, (01)00884838095076(21)39003, (01)00884838095076(21)39024, (01)00884838095076(21)39031, (01)00884838095076(21)39037, (01)00884838095076(21)72054, (01)00884838095076(21)72243, (01)00884838095076(21)72250, (01)00884838098886(21)10128, (01)00884838098886(21)21893, (01)00884838098886(21)32580, (01)00884838098886(21)32798; Serial No. 5447, 5463, 5479, 5490, 5537, 5546, 8012, 8025, 8054, 8086, 8087, 8091, 8092, 8110, 8118, 8178, 8260, 8311, 8318, 8365, 8378, 8387, 8392, 8395, 8427, 8554, 8566, 8578, 8611, 8616, 8639, 8642, 8667, 8706, 8713, 8746, 8750, 8752, 8779, 8783, 8786, 8831, 8840, 8851, 8857, 8884, 8895, 8896, 8923, 8942, 8948, 9004, 9013, 10029, 10044, 10075, 10079, 10130, 10151, 10164, 10170, 10174, 10185, 10191, 10458, 10511, 10513, 10554, 10906, 10915, 11031, 11047, 11062, 11076, 11085, 11091, 11102, 12030, 13011, 13029, 13032, 13062, 18038, 18670, 18761, 18957, 20071, 20111, 20226, 21062, 21213, 21576, 21582, 21801, 21814, 22013, 22017, 22031, 22086, 22098, 22102, 22144, 22157, 22248, 30033, 32218, 33044, 33246, 39003, 39024, 39031, 39037, 72054, 72243, 72250, 10128, 21893, 32580, 32798.
Where was it sold?
Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.
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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