PlainRecalls
FDA Devices Moderate Class II Terminated

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

Reported: March 6, 2013 Initiated: January 18, 2013 #Z-0885-2013

Product Description

Elekta, Apex add-on Micro MLC, collimator for radiation therapy.

Reason for Recall

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.

Details

Recalling Firm
Elekta, Inc.
Units Affected
1
Distribution
Nationwide Distribution including TX
Location
Atlanta, GA

Frequently Asked Questions

What product was recalled?
Elekta, Apex add-on Micro MLC, collimator for radiation therapy.. Recalled by Elekta, Inc.. Units affected: 1.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2013. Severity: Moderate. Recall number: Z-0885-2013.