FDAFDA · Food and drugs·Recall number Z-1724-2014
Synergy XVI Intended for radiation therapy treatment.
Published June 25, 2014 · Recall initiated: April 23, 2014
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
XVI can incorrectly calculate the target position of the treatment table.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.
- Lot
- XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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