Reported Jul 13, 2016 · Terminated
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Esaote S.p.A.
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: Esaote S.p.A. · Via Di Caciolle,15 · Firenze, N/A · N/A
Is this the product you have?
- Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
- Lot codes and dates
Item NoUnit Description and Serial No.s: 101002000UNITG-SCAN BRIO05202101002000UNITG-SCAN BRIO05203101002000UNITG-SCAN BRIO 2.1A05205101002000UNITG-SCAN BRIO 2.1A05207101002000 UNITG-SCAN BRIO 2.1A05208101002000 UNITG-SCAN BRIO 2.1A05209101002000 UNITG-SCAN BRIO 2.1A05210101002000 UNITG-SCAN BRIO 2.1A05211101002000 UNITG-SCAN BRIO 2.1A05305101002000 UNITG-SCAN BRIO 2.1A05308
- Amount recalled
- 11 USA; 29 OUS
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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