FDA Medical Device Recalls (openFDA)
Esaote S.p.A.: Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
- Recall number
- Z-2124-2016
- Recalling firm
- Esaote S.p.A.
- Product
- Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
- Status
- Terminated
- Initiated
- 2016-06-06
- Posted
- 2016-07-05
- Terminated
- 2017-05-30
- 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.
- 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 quality@esaoteusa.com. 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 quality@esaoteusa.com, 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
- 11 USA; 29 OUS
- Distribution
- Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K142421"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3002806925
- Firm city
- Firenze
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28