Device product
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Z-2124-2016
Product summary
- Firm
- Esaote S.p.A.
- Event
- Event 74391
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 USA; 29 OUS
- Official record key
device-enforcement:Z-2124-2016
Official wording
Reason: 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.
Code information: 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
Distribution pattern: Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
Derived failure modes
-
Unknown
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.