Reported Sep 1, 2021 · Terminated
Ingenia 1.5T-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
Is this the product you have?
- Ingenia 1.5T-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 Number781341
- Lot codes and dates
- S/N and UDI
84344 (01)00884838055322(21)8434487019 (01)00884838055322(21)8701987231 (01)00884838055322(21)87231
- OUS87171 (01)00884838055322 84943 (01)00884838055322 87142 (01)00884838055322 87249 (01)00884838055322 87252 (01)00884838055322 87195 (01)00884838055322 87129 (01)00884838055322 87136 (01)00884838055322 87175 (01)00884838055322 87196 (01)00884838055322 87197 (01)00884838055322 87235 (01)00884838055322 87187 (01)00884838055322 87212 (01)00884838055322 84572 (01)00884838055322 87116 (01)00884838055322 87152 (01)00884838055322 87161 (01)00884838055322 87237 (01)00884838055322 87244 (01)00884838055322 87090 (01)00884838055322 87093 (01)00884838055322 87259 (01)00884838055322 87209 (01)00884838055322
- S/N and UDI
- Amount recalled
- 3 units US; 24 units OUS
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
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.
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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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