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U.S. Department of Health and Human Services

Class 2 Device Recall Esaote GScan Brio

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  Class 2 Device Recall Esaote GScan Brio see related information
Date Initiated by Firm June 06, 2016
Date Posted July 05, 2016
Recall Status1 Terminated 3 on May 30, 2017
Recall Number Z-2124-2016
Recall Event ID 74391
510(K)Number K142421  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
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 
Recalling Firm/
Manufacturer		 Esaote S.p.A.
Via Di Caciolle,15
Firenze Italy
For Additional Information Contact Alan Voils
317-813-6000
Manufacturer 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 Determined
Cause 2		 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 in Commerce 11 USA; 29 OUS
Distribution Domestic: FL, TX, OH, MN, NV; Foreign: No customers in Canada; No VA/DOD.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = ESAOTE, S.P.A.
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