Reported Sep 15, 2021 · Completed
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system…
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 Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body
- or extremities Models781357
- Lot codes and dates
- Serial Number Unique Device Identifier (UDI#)
- Model781357 46029 (01)00884838088108(21)46029 46053 (01)00884838088108(21)46053 46045 (01)00884838088108(21)46045 46027 (01)00884838088108(21)46027 46042 (01)00884838088108(21)46042 46084 (01)00884838088108(21)46084 46086 (01)00884838088108(21)46086 46083 (01)00884838088108(21)46083 46030 (01)00884838088108(21)46030 46031 (01)00884838088108(21)46031 46050 (01)00884838088108(21)46050 46049 (01)00884838088108(21)46049 46052 (01)00884838088108(21)46052 46076 (01)00884838088108(21)46076 46085 (01)00884838088108(21)46085 46024 (01)00884838088108(21)46024 46044 N/A 46061 N/A 46001 (01)00884838088108(21)46001 46005 (01)00884838088108(21)46005 46011 (01)00884838088108(21)46011 46012 (01)00884838088108(21)46012 46057 (01)00884838088108(21)46057 46048 (01)00884838088108(21)46048 46021 (01)00884838088108(21)46021 46066 (01)00884838088108(21)46066 46078 (01)00884838088108(21)46078 46081 (01)00884838088108(21)46081 46060 (01)00884838088108(21)46060 46004 (01)00884838088108(21)46004 46018 (01)00884838088108(21)46018 46020 (01)00884838088108(21)46020 46013 (01)00884838088108(21)46013 46015 (01)00884838088108(21)46015 46017 (01)00884838088108(21)46017 46016 (01)00884838088108(21)46016 46023 (01)00884838088108(21)46023 46033 (01)00884838088108(21)46033 46034 (01)00884838088108(21)46034 46037 (01)00884838088108(21)46037 46025 (01)00884838088108(21)46025 46041 (01)00884838088108(21)46041 46026 (01)00884838088108(21)46026 46032 (01)00884838088108(21)46032 46036 (01)00884838088108(21)46036 46059 (01)00884838088108(21)46059 46039 (01)00884838088108(21)46039 46075 (01)00884838088108(21)46075 46046 (01)00884838088108(21)46046 46068 (01)00884838088108(21)46068 46058 (01)00884838088108(21)46058 46054 (01)00884838088108(21)46054 46082 (01)00884838088108(21)46082 46069 (01)00884838088108(21)46069 46003 (01)00884838088108(21)46003 46019 (01)00884838088108(21)46019 46008 (01)00884838088108(21)46008 46007 (01)00884838088108(21)46007 46067 (01)00884838088108(21)46067 46089 N/A 46002 (01)00884838088108(21)46002 46014 (01)00884838088108(21)46014 46065 (01)00884838088108(21)46065 46077 (01)00884838088108(21)46077
- Amount recalled
- 64 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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