Recall Record

Sunnyvale, CA, United States

Elekta Impac Software recalls

1 recall recorded since 2018, most recently on 24 September 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
24 September 2019
Reason
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Distribution
Worldwide distribution.
Initiated
Voluntary: Firm initiated
Recall number
Z-1597-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.