Device product
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Z-2157-2013
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 66048
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-2157-2013
Official wording
Reason: Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.
Code information: EM-042, EM7-004, EM-046, EM-060, EM-047, EM-029, EM7-003, EM7-002, EM7-008, EM-062, EM-063, EM3-004, 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116068, 116013, 116046
Distribution pattern: Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
Derived failure modes
-
Unknown
Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.