FDA-Device2016-07-13Class II
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Esaote S.p.A.
Hazard
The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Additionally, a weight limit is added to the patient seat for weight-bearing examinations.
Sold states
Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
Affected count
11 USA; 29 OUS
Manufactured in
Via Di Caciolle,15, N/A, Firenze, N/A, Italy
Products
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2124-2016Don't want to check this manually?
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