Elekta, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1724-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Synergy XVI Intended for radiation therapy treatment.

Product Classification:

Class II

Date Initiated: April 23, 2014

Date Posted: June 25, 2014

Recall Number: Z-1724-2014

Event ID: 68255

Reason for Recall:

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

Status: Terminated

Product Quantity: 380 US

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.

Voluntary or Mandated:

Voluntary: Firm initiated