Reported May 22, 2024 · Ongoing
Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated…
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 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated
- for use as a diagnostic device REF782117
- Lot codes and dates
- UDI-DI(01)00884838099739(21)
- Serial Numbers
42029422174224671044717748514685645856638566485668856778568085681856858570085704857058570685713
- Amount recalled
- 19 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
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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