Recall Z-1061-2014 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
| Date | Feb 20, 2014 (initiated Nov 25, 2013) |
| Status | Terminated |
| Reason | Potential collision risk when using XVI and external beam shaping devices. |
| Root cause | Software design |
| Action | Elekta sent an Important Field Safety Notice dated November 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Corrective Action #1 - Potential collision risk when using XVI and external beam shaping devices. (Only software version R4.2.1 from this notice are applicable to this recall). Recommendations to Users - Monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the FKP. To correct the error - (1) Restart XVI. (2) Put the patient in their |
| Quantity | 312 |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico and the states of: AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Bra |
| 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 |