Reported Dec 30, 2015 · Terminated
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Siemens Medical Solutions USA, Inc.
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: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
- Lot codes and dates
- all units distributed since 1991
- Amount recalled
- in US 3752 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.
This product could cause temporary or reversible health problems — stop using it.
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