FDAFDA · Food and drugs·Recall number Z-2340-2012
Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Published September 19, 2012 · Recall initiated: July 27, 2012
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
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Nationwide Distribution including DC & MD
- Lot
- 152599 and 152678
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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