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Recall Observatory FDA recall evidence

Device product

DMLC IV-ERGO - Beam shaping block for Radiation Therapy.

Z-2157-2013

August 15, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are incorrect.