Recall Z-1405-2010 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Apr 16, 2010 (initiated Dec 12, 2008) |
| Status | Terminated |
| Reason | It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing. |
| Root cause | Software design |
| Action | Elekta, Inc. issued an "Important Notice" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided. For further information, contact Elekta, Inc. at 1-770-300-9725. |
| Quantity | 76 units |
| Distribution | Nationwide Distribution -- AL, AZ, CO, CT, FL, GA, ID, KS, KY, MA, MI, MN, MS, NE, NY, OH, OK, OR, PA, TN, TX, VA, WA and WV. |
| 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 |