FDAClass IISeptember 11, 2013

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

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

Why was DMLC IV-ERGO - Beam shaping block for Radiation Therapy recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DMLC IV-ERGO - Beam shaping block for Radiation Therapy.
Recalling firm
Elekta, Inc.
Quantity
31
Distribution
Nationwide distribution: AL, CT, FL, GA, IA, MS, MO, NJ, NY, ND, OH, OK, PA, RI, TX, VA and Puerto Rico.
Recall date
September 11, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls