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Recall Observatory FDA recall evidence

Device product

Synergy XVI Intended for radiation therapy treatment.

Z-1724-2014

April 23, 2014

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 68255
Status
Terminated
Classification
Class II
Quantity
380 US
Official record key
device-enforcement:Z-1724-2014

Official wording

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

Code information: XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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