Elekta, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2157-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 15, 2013

Date Posted: September 11, 2013

Recall Number: Z-2157-2013

Event ID: 66048

Reason for Recall:

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

Status: Terminated

Product Quantity: 31

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.

Voluntary or Mandated:

Voluntary: Firm initiated