FDAClass IIMarch 5, 2014

DMLC IV-ERGO Product Usage: Intended for use with recall

DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of…

Why was DMLC IV-ERGO Product Usage: Intended for use with recalled?

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

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?

Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046

Product
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of…
Recalling firm
Elekta, Inc.
Quantity
35 units
Distribution
US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
Recall date
March 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls