Recalls / —

—#121330

Product

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

FDA product code

IXI — Block, Beam-Shaping, Radiation Therapy

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K001163

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

Important Field Safety Notices 200 01 406 030 (Changes to your system to improve the safe operation of DMLC) and 200 01 602 031 (Changes to your system to improve the safe operation of 3DLINE DMLC) letters were sent to customers on 8/15/2013 advising them of the issue and recommendations to resolve either by upgrading their system or to discontinue a clinical use of the device.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.

Timeline

Recall initiated

2013-08-15

Posted by FDA

2013-09-04

Terminated

2015-07-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #121330. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.