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

FDA device recall Z-2124-2016 · posted 2016-07-05 · Terminated

Recall details

Recalling firm

Esaote S.p.A.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LNH

Quantity affected

11 USA; 29 OUS

Distribution

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

Date initiated

2016-06-06

Date posted

2016-07-05

Date terminated

2017-05-30

Location

Firenze, Italy

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