Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as de

FDA device recall Z-1088-2015 · posted 2015-02-10 · Terminated

Recall details

Recalling firm: Elekta, Inc.
Reason for recall: Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
Action taken: Elekta sent an Urgent Important Field Safety Notice on January 7, 2015, to all affected customers. Elekta recommended that customers replace the M20 x 50 MM bolts marked 'OF' on the gantry counterbalance frame immediately. The digital linear accelerator must not be used until these 'OF' bolts are replaced. Elekta recommended that customers put the machine in a parked position at 0, and attach the gantry locking straps. A Modification kit will be available as soon as possible which contains the correct bolts. Customers were instructed to complete the Important Field Safety Notice Acknowledgement form and return to their local Elekta Office or Representative. Customers with questions were instructed to contact their local Elekta representative. For questions regarding this recall call 404-993-5886.
Root cause: Other
Status: Terminated
Product code: IYE
Quantity affected: 46
Distribution: Worldwide Distribution - USA including AZ, CA, FL, KS, LA, MN, MO, NY, NC and Internationally to Austria, Bulgaria, Canada, China, Germany, Hungary, Italy, Malaysia, Malta, Netherlands, Norway, Russia
Date initiated: 2015-01-07
Date posted: 2015-02-10
Date terminated: 2016-04-14
Location: Atlanta, GA

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 (K051932)	Elekta, Inc.	2005-08-12