Reported Sep 1, 2021 · Terminated
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The…
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 Evoluton- 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 Number781315
- Lot codes and dates
- S/N and UDI
US: 61044 (01)00884838099715(21)6104461047 (01)00884838099715(21)61047
- OUS61028 (01)00884838099715 61008 (01)00884838099715 61025 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715 61018 (01)00884838099715 61017 (01)00884838099715 61032 (01)00884838099715 61043 (01)00884838099715 61033 (01)00884838099715 61064 (01)00884838099715
- S/N and UDI
- Amount recalled
- 2 units US; 16 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.
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.