FDAFDA · Food and drugs·Recall number Z-0978-2014
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.
Published March 5, 2014 · Recall initiated: May 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- US Nationwide Distribution in the states of CT, FL, GA, IA, MO, NY, ND, OK, RI, TX, VA, WA
- Lot
- Identifier : 116001, 116012, 116044, 116055, 116014, 116052, 116023, 116056, 116053, 116043, 116047, 116051, 116122, 116063, 116068, 116013, 116046
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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