Device product

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

Z-0885-2013

January 18, 2013

Class II

Product summary

Firm: Elekta, Inc.
Event: Event 64213
Status: Terminated
Classification: Class II
Quantity: 1
Official record key: device-enforcement:Z-0885-2013

Official wording

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.

Code information: 152652

Distribution pattern: Nationwide Distribution including TX

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.