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.
Reported: March 5, 2014 Initiated: May 1, 2013 #Z-0978-2014
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
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 35 units
- Distribution
- US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Elekta, Inc.. Units affected: 35 units.
Why was this product recalled? ▼
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Moderate. Recall number: Z-0978-2014.
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