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 Recall Z-0978-2014 · Posted 2014-02-25
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIXI
Date Initiated2013-05-01
Date Terminated2015-01-29
Product Quantity35 units
Reason for Recall
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Firm Action
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
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.