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Recall Observatory FDA recall evidence

Device product

Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)

Z-2124-2016

June 06, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    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.