Recall Z-2721-2016 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Medical Linear Accelerator
| Date | Jul 8, 2016 |
| Status | Terminated |
| Reason | There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. |
| Root cause | Other |
| Action | Important Field Safety Notice 200-01-103-081 was released July 8, 2016 for distribution to all customers with Digital Accelerators without XVI. It informs users of the specific product and version numbers affected by the issue. The modification involves an inspection and correction procedure. Should the inspection pass, the corrected in not required. All gantry base wheel bolts should be checked for presence and torque and should be replaced if found to be showing signs of fatigue. Elekta service is actively reaching out to affected customers in order to organize a time to implement the i |
| Quantity | 553 |
| Distribution | AL, AZ, CA, FL, GA, KY, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, WA, WV, Argentina, Austria, Australia, Bosnia and Herzegovinia, Bangladesh, Belgium, Bulgaria, Brazil, China, Columbia, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Isra |
| 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 |