Reported Sep 1, 2021 · Terminated
Ingenia Elition X-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 X-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 Number781358
- Lot codes and dates
- S/N and UDI
US: 45245 (01)00884838088115(21)4524545247 (01)00884838088115(21)4524745261 (01)00884838088115(21)4526145263 (01)00884838088115(21)4526345264 (01)00884838088115(21)4526445269 (01)00884838088115(21)45269
- OUS
45215 (01)0088483808811545284 (01)0088483808811545253 (01)0088483808811545313 (01)0088483808811545265 (01)0088483808811545297 (01)0088483808811545218 (01)0088483808811545272 (01)0088483808811545281 (01)0088483808811545231 (01)0088483808811545278 (01)0088483808811545279 (01)0088483808811545245 (01)0088483808811545247 (01)00884838088115
- S/N and UDI
- Amount recalled
- 6 units; 12 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.
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.
Free recall alerts
Get alerted about new Philips North America LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.