Recall Z-1322-2014— Elekta, Inc.
Class II · Terminated
Class II FDA medical device recall by Elekta, Inc., initiated 2013-03-28, terminated 2017-07-26. It names one FDA 510(k) clearance: K112613. Product: Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.. Reason: The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values..
- Recalling firm
- Elekta, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2017-07-26
- Firm location
- Atlanta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Reason for recall
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
Data sourced from openFDA. This site is unofficial and independent of the FDA.