Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0978-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: May 1, 2013

Date Posted: March 5, 2014

Recall Number: Z-0978-2014

Event ID: 65309

Reason for Recall:

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

Status: Terminated

Product Quantity: 35 units

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

Voluntary or Mandated:

Voluntary: Firm initiated