Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
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
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
UDI-DI: (1) 782129 (01)00884838105805(21); (2) 782113 (01)00884838098909(21); (3) 781270 (01)00884838095083(21) Serial Numbers: Serial Number 17536 17546 17212 17508 23011 35056 17434 17302 17429 24108 17006 17378 17386 17533 17590 35052 17204 17264 17292 17339 17398 17415 17416 17436 17440 17447 17544 23030 24055 35087 17473 17283 17247 17265 17268 17286 17353 17367 17389 17425 17509 17517 17572 17580 24022 24036 24098 35020 35078 23002 24018 17514 17524 23026 24087 24095 17260 17222 17242 17245 17250 17269 17299 17308 17309 17342 17357 17388 17399 17464 17468 17493 17499 17556 17559 17564 17565 17569 17589 17594 24006 24012 24023 24047 24109 24110 24111 24124 24134 24143 35027 35046 35048 38015 17305 24117 17266 17471 17428 38131 17194 17246 23036 17610 17550 24145 34250 17237 17352 17321 17344 17495 17570 17615 24020 24090 17274 35047 17326 17466 24075 17172 17360 17369 17490 24007 24025 38199 17356 17406 17206 17239 17240 17284 17375 17459 17516 23033 24058 24076 35019 35032 35040 17366 17215 17376 17449 17455 17470 34059 34262 38106 17252 34172 38070 38142 17439 38350 74040 17504 34072 35041 38105 17271 17346 24021 24077 24093 24146 34117 34127 34128 34129 34131 34153 34202 35059 38094 38290 38311 17258 38310 34212 38042 38281 17560 38166 38183 24039 34110 38117 17521 38010 38219 17307 38075 38222 34055 38195
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Recall record
- Recalling firm
- Philips North America Llc
- Product type
- Devices
- Recall number
- Z-1862-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Cambridge, MA
- Recall initiated
- 2024-05-03
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1862-2024 · Source: openFDA enforcement.