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Recall Observatory FDA recall evidence

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

May 01, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems