Esaote S.p.A.: Medical Device Recall in 2016 - (Recall #: Z-2124-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 6, 2016

Date Posted: July 13, 2016

Recall Number: Z-2124-2016

Event ID: 74391

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11 USA; 29 OUS

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.

Voluntary or Mandated:

Voluntary: Firm initiated