Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
FDA Recall Z-1237-2018 · Posted None
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2017-12-13
Date Terminated2020-04-14
Product Quantity2121
Reason for Recall
Product reportedly shutting down during use.
Firm Action
The firm, Medtronic, sent a "Field Corrective Action Notice" dated 12/13/2017 to all consignees via Federal Express or certified mail on 12/13/17. The notice described the product, problem and actions to be taken. Customers were instructed to: immediately notify all users of Signia power handles of this important notification; follow the User manual and Instructions for Use; If your facility has distributed Signia" power handles to other persons or facilities, please promptly forward a copy of this letter to those recipients, and complete and return the Field Corrective Action Acknowledgement Form via Fax to (203) 492-7719 or email to: [email protected]. All in-control inventory and product at customers locations will have the software update installed.
If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution: US (Nationwide).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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