Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear acce
FDA device recall Z-1085-2014 · posted 2014-03-06 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
- Action taken
- Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 043 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Corrective Action #2 - Permanent Solution - All users of Integrity 3.1 software will be informed or a mandatory upgrade to Integrity 3.2 upon its release which will prevent calibration from being inverted. Target Release for Integrity 3.2 will be available at the end of February 2014.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 134
- Distribution
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, V
- Date initiated
- 2013-11-25
- Date posted
- 2014-03-06
- Date terminated
- 2017-11-08
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILITY (K123808) | Elekta , Ltd. | 2013-04-04 |