Reported May 29, 2024 · Ongoing
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic…
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?
- Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as
- a diagnostic device Model Number (REF)
(1) 782138(2) 782109(3) 781356
- Lot codes and dates
- UDI-DI(1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number
508 of 508 codes
471944704047092470914704847195473454736147050472094724647247472934725447275470194704947200473564735747197472704701347014470154705347065470824709947268472744700047002470034701747020470244703547047470564705847074470784708947097471924722547337472264722747341473074736447365473724728447350470574707547081
- UDI-DI(1) 782138 (01)00884838108622(21); (2) 782109 (01)00884838098350(21); (3) 781356 (01)00884838090040(21); Serial Number
- Amount recalled
- 509 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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