Recall Z-1724-2014— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2014-04-23, terminated 2017-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Synergy XVI Intended for radiation therapy treatment.. Reason: XVI can incorrectly calculate the target position of the treatment table..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-23
- Terminated
- 2017-07-17
- Firm location
- Atlanta, GA, United States
Product description
Synergy XVI Intended for radiation therapy treatment.
Reason for recall
XVI can incorrectly calculate the target position of the treatment table.
Data sourced from openFDA. This site is unofficial and independent of the FDA.