Esaote S.p.A. recalls Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
- Recall date
- June 6, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2124-2016
- FDA classification
- Class II
- Brand / firm
- Esaote S.p.A.
- Sold / distributed
- Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
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