FDA Recall
Terminated
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Recall: Z-0978-2014
·
Initiated May 1, 2013
Recall
- Recall Number
- Z-0978-2014
- Event Number
- 65309
- Firm
- Elekta, Inc.
- FEI Number
- 1037831
- Product Code
- IXI
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- May 1, 2013
- Posted
- February 25, 2014
- Terminated
- January 29, 2015
- Address
- 400 Perimeter Center Ter Ne, Ste 50, Atlanta, GA, 30346-1227
Description
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
Reason
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Action
Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422
Distribution
US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
Quantity
35 units