Reported May 29, 2024 · Ongoing
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic…
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 CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
- Model Number (REF)(1) 781262 (2) 781261
- Lot codes and dates
- UDI-DI
(1) 781262 (01)00884838068445(21)(2) 781261 (01)00884838068438(21)
- Serial NumbersSerial Number
146 of 146 codes
770087700077004770017701977010770147700777002770167713177070771247714477172770747704877177771787718177031770477713477050770517706077194770347703777038770577707277075770787708477085770867709277101771107715677157770357711177119771677718377185771877718877195771967719877199772027705277053770547705577056
- UDI-DI
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
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.