Device product
Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures
Z-1187-2016
Product summary
- Event
- Event 73438
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,920 units
- Official record key
device-enforcement:Z-1187-2016
Official wording
Reason: Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna.
Code information: Model Numbers: CA15L1, CA20L1 and CA30L1
Distribution pattern: Worldwide Distribution - US Nationwide, VA/govt/military consignees.
Derived failure modes
-
Unknown
Medtronic is voluntarily recalling specific item codes and production lots of Covidien Emprint" Percutaneous Antenna with Thermosphere" Technology due to the potential for the generator to shut down in the precence of high temperature measurements in the Emprint" Percutaneous Antenna.