Reported Dec 14, 2022 · Ongoing
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
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?
Philips Ingenia Elition S MR SystemModel Numbers 781357782106782137
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 78135700884838088108UDI-DI: 00884838088108 — Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071 78210600884838098329UDI-DI: 00884838098329 — Serial Numbers: 46224 46225 46265 46269 46311 78213700884838108615UDI-DI: 00884838108615 — Serial Numbers: Included in Letter but No Devices Distributed in the US. - Amount recalled
- 566 total
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
This product could cause temporary or reversible health problems — stop using it.
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