Recall Z-1088-2015 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Feb 10, 2015 (initiated Jan 7, 2015) |
| Status | Terminated |
| Reason | Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail. |
| Root cause | Other |
| Action | 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 Acknowled |
| Quantity | 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, Spain, Sweden, Taiwan and Ukraine. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051932 | ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 Elekta, Inc., Aug 12, 2005 |