Reported Apr 25, 2018 · Terminated
Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492,…
Philips Electronics North America Corporation
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 Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
781487 | Magnets Multiva 16 |
781488 | Magnets 8 |
781492 | Magnet Achieva 1.5T |
781495 | Magnet HFO |
781496 | Magnet Multiva 16 |
781497 | Magnet Multiva 8, & |
781498 | Magnets Ingenia 1.5T CX, Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities. |
- Lot codes and dates
- None
- Amount recalled
- 8,205 units in total
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
Potential risk for helium gas inside the MR examination room during a magnet quench
This product could cause temporary or reversible health problems — stop using it.
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