Reported Sep 1, 2021 · Terminated

Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can…

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

Ingenia CX 3.0T-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 Model Number78127 (OUS)

Lot codes and dates: S/N and UDI
78189 (01)00884838068452
78272 (01)00884838068452
78294 (01)00884838068452
78295 (01)00884838068452
78332 (01)00884838068452
78335 (01)00884838068452
78340 (01)00884838068452
78345 (01)00884838068452
78249 (01)00884838068452
78324 (01)00884838068452
78326 (01)00884838068452
Amount recalled: 11 units

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

This product could cause temporary or reversible health problems — stop using it.

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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70 in total.