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Esaote S.p.A. recalls Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Recalled July 13, 2016 · FDA recall Z-2124-2016 · 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. · FDA Class II
Units
11 USA; 29 OUS
Sold at
Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
Description
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.
Product
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Manufacturer(s)
Esaote S.p.A.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →