Reported May 29, 2024 · Ongoing
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device…
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?
- AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as
- a diagnostic device Model Number (REF)781253
- Lot codes and dates
- UDI-DIN/A
- Serial Numbers
35062350283506835081350553506935084350243502535070350073501335064350713508335022350633507435049350353506735004350063501135015350163502135050350573506135075350763508235085
- Amount recalled
- 35 units
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.
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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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