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.
Reported: April 4, 2018 Initiated: December 13, 2017 #Z-1237-2018
Product Description
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.
Reason for Recall
Product reportedly shutting down during use.
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- 2121
- Distribution
- Worldwide Distribution: US (Nationwide).
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Covidien LLC. Units affected: 2121.
Why was this product recalled? ▼
Product reportedly shutting down during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1237-2018.
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