Recall Z-0978-2014— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2013-05-01, terminated 2015-01-29. It names one FDA 510(k) clearance: K001163. 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.. Reason: It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems.
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-01
- Terminated
- 2015-01-29
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Data sourced from openFDA. This site is unofficial and independent of the FDA.