Reported May 29, 2024 · Ongoing
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
- Model Number (REF)
(1) 782129(2) 782113(3) 781270
- Lot codes and dates
- UDI-DI
(1) 782129 (01)00884838105805(21)(2) 782113 (01)00884838098909(21)(3) 781270 (01)00884838095083(21)
- Serial NumbersSerial Number
199 of 199 codes
175361754617212175082301135056174341730217429241081700617378173861753317590350521720417264172921733917398174151741617436174401744717544230302405535087174731728317247172651726817286173531736717389174251750917517175721758024022240362409835020350782300224018175141752423026240872409517260172221724217245
- UDI-DI
- Amount recalled
- 200 units
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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