Magnetic Resonance System G-scan Brio recall
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Why was Magnetic Resonance System G-scan Brio 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.
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?
Item No., Unit Description and Serial No.s: 101002000, UNIT, G-SCAN BRIO, 05202; 101002000, UNIT, G-SCAN BRIO, 05203; 101002000, UNIT, G-SCAN BRIO 2.1A; 05205; 101002000, UNIT, G-SCAN BRIO 2.1A, 05207; 101002000 UNIT, G-SCAN BRIO 2.1A, 05208; 101002000 UNIT, G-SCAN BRIO 2.1A, 05209; 101002000 UNIT, G-SCAN BRIO 2.1A, 05210; 101002000 UNIT, G-SCAN BRIO 2.1A, 05211; 101002000 UNIT, G-SCAN BRIO 2.1A, 05305; 101002000 UNIT, G-SCAN BRIO 2.1A, 05308
- Product
- Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
- Recalling firm
- Esaote S.p.A.
- Quantity
- 11 USA; 29 OUS
- Distribution
- Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
- Recall date
- July 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)