Synergy XVI Intended for radiation therapy treatment.

FDA device recall Z-1724-2014 · posted 2014-06-16 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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

Action taken

Elekta is responsible for the correction of all products with this defect. 1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury. 2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014. 3. The software correction will enable verification that values have been assigned to table position parameters; failure to pass verification will inhibit the system. The software correction will also detect internal communication errors (incomplete registrations) and inhibit the system when those errors are detected. 4. The update will be mandatory and will be made at no cost to the users. CDRH approves this CAP. You may proceed with implementation of the CAP. For further questions please call (770) 670-2422.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity 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.

Date initiated

2014-04-23

Date posted

2014-06-16

Date terminated

2017-07-17

Location

Atlanta, GA