Recall Z-2405-2012 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Precise Digital Accelerator Delivery of radiation to defined target volumes
| Date | Sep 19, 2012 (initiated Aug 6, 2012) |
| Status | Terminated |
| Reason | There have been a small number of 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 | Nonconforming Material/Component |
| Action | Elekta sent an Important Field Safety Notice dated August, 2012 to inform users that inspection and possibly bolt replacement needs to be carried out. Users should return the signed acknowledgement to Elketa, and an inspection should be carried out under FCO20002103053. For questions customers should call +44(0)1293 654200. For questions regarding this recall call 770-300-9725. |
| Quantity | 110 |
| Distribution | Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IA, MD, MA, MI, MN, NE, NV, NJ, NM, NY, ND, OH, OK, OR, PA, VA, SC, TN TX, WA, WV, WI and Puerto |
| 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 |