—#118524

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.

FDA product code: IXI — Block, Beam-Shaping, Radiation Therapy
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K001163
Affected lot / code info: Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

Elekta sent an Important Field Safety Notice letter dated May 2013 to affected customers. The letter identified the scope, problem, clinical impact, solution, and safety reference. For question call +44 (0)1293 544422

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA

Timeline

Recall initiated: 2013-05-01
Posted by FDA: 2014-02-25
Terminated: 2015-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118524. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.