Z-2124-2016Class II

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

Name: Z-2124-2016 Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Creator: Esaote S.p.A.
Published: 2016-06-06
License: https://open.fda.gov/license/

Esaote S.p.A. / initiated 2016-06-06 / Terminated

FDA source

Esaote S.p.A. began a recall of Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) on 2016-06-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2124-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-06
Posted: 2016-07-05
Terminated: 2017-05-30
Recalling firm: Esaote S.p.A.
Product: Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Product code: LNH System, Nuclear Magnetic Resonance Imaging
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.
FDA root cause: Other
Action: Esaote initiated a voluntary recall of the G-scan Brio Magnetic Resonance System on 06/06/2016 with letters sent via certified, due to a potential weakness on the extremity areas of the patient table that could lead to a stress fracture of the table. The firm has instructed customers to refer to the Medical Device Safety Notification provided with the recall notice, date and sign this letter in the space provided on the last page and send it back via email to [email protected]. If customers have questions regarding the recall, please call 1-317-813-6030. For additional information, please contact us by phone during normal business hours, Monday-Friday from 8:00am 5:00pm Eastern Standard Time, via email at [email protected], or at any time by visiting our website. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by regular mail using the postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatchgetforms.htm or by fax to 1-800-FDA-0178.
Quantity in commerce: 11 USA; 29 OUS
Distribution: Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2124-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-05

Product code LNH

K142421Class IIG-scan BrioEsaote, S.p.A. / cleared 2015-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)