CLASS II Device recall · Reported 13 Jul 2016 · FDA Enforcement Report

Magnetic Resonance System G-scan Brio recalled by Esaote S.p.A

Esaote is recalling Magnetic Resonance System G-scan Brio (, distributed in Florida, Minnesota, Nevada, Ohio, Texas, Virginia. The recall was initiated on 6 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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

Quantity recalled11 USA; 29 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2124-2016
FDA event ID: 74391
Recalling firm: Esaote, Firenze, N/A
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2016
FDA classified: 5 Jul 2016
Reported: 13 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Jun 2016	Recall initiated by company
5 Jul 2016	Classified by FDA	+29 days
13 Jul 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.

Florida Minnesota Nevada Ohio Texas Virginia

Questions about this recall

Why was it recalled?

Which lots 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

Where was it sold?

Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Esaote

All 9

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Endocavity ultrasonic probe recalled by Esaote S.p.a	Esaote	Packaging Defects	Nationwide
7 Oct 2020Device	CLASS II	AC/DC Power Supply recalled by Esaote S.p.a	Esaote	Other	Nationwide
7 Oct 2020Device	CLASS II	AC/DC Power Supply recalled by Esaote S.p.a	Esaote	Other	Nationwide
31 Oct 2018Device	CLASS II	MyLab Seven recalled by Esaote S.p.a	Esaote	Device Malfunction	Nationwide
31 Oct 2018Device	CLASS II	MyLab Alpha recalled by Esaote S.p.a	Esaote	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,929

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Rapicide PA Part A High-Level Disinfectant recalled by Steris	Steris	Other	Nationwide
21 Oct 2026Device	CLASS II	NeuroStar Advanced Therapy System recalled by Neuronetics	Neuronetics	Other	Nationwide
21 Oct 2026Device	CLASS II	TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics	Howmedica Osteonics	Sterility	NJ
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide
21 Oct 2026Device	CLASS II	BD Phoenix Panel Nmic recalled by Becton Dickinson	Becton Dickinson	Device Malfunction	Nationwide