Device product
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.
Z-0978-2014
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 65309
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35 units
- Official record key
device-enforcement:Z-0978-2014
Official wording
Reason: It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Code information: Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046
Distribution pattern: US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
Derived failure modes
-
Unknown
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems