Philips North America Llc 2024-05-29 Health serious FDA
Health · FDA · Recall #FDA-Z-1851-2024
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems… Recall
Issued May 29, 2024 · Philips North America Llc
In May 2024, Philips North America Llc recalled the Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America Llc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips North America Llc
- Category
- Health
- Recall date
- May 29, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, Fra
- Recall number
- FDA-Z-1851-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America Llc has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.