MAGNETOM systems recall
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Why was MAGNETOM systems 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all units distributed since 1991
- Product
- MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- in US 3752 units
- Distribution
- Nationwide including : DC, PR, Virgin Islands and Bermuda
- Recall date
- December 30, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)