FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
- Recall number
- Z-0885-2013
- Recalling firm
- Elekta, Inc.
- Product
- Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
- Status
- Terminated
- Initiated
- 2013-01-18
- Posted
- 2013-02-26
- Terminated
- 2014-05-08
- Reason
- If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
- Root cause
- Employee error
- Action
- Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.
- Quantity
- 1
- Distribution
- Nationwide Distribution including TX
- Lot, serial or model codes
- 152652
- 510(k) numbers
- ["K111676"]
- PMA numbers
- not on file
- Product code
- IXI
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28