Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Recall Z-2405-2012 · Posted 2012-09-19
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-08-06
Date Terminated2014-10-08
Product Quantity110
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.