PlainRecalls
FDA Devices Moderate Class II Terminated

Synergy XVI Intended for radiation therapy treatment.

Reported: June 25, 2014 Initiated: April 23, 2014 #Z-1724-2014

Product Description

Synergy XVI Intended for radiation therapy treatment.

Reason for Recall

XVI can incorrectly calculate the target position of the treatment table.

Details

Recalling Firm
Elekta, Inc.
Units Affected
380 US
Distribution
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.
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled?
Synergy XVI Intended for radiation therapy treatment.. Recalled by Elekta, Inc.. Units affected: 380 US.
Why was this product recalled?
XVI can incorrectly calculate the target position of the treatment table.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 25, 2014. Severity: Moderate. Recall number: Z-1724-2014.