Product Wiki · Recalls · U.S. FDA — Device Enforcement

Leksell GammaPlan 11.1 — recall Z-1412-2019

U.S. FDA — Device Enforcement · Sweden · 2018-06-27 · Class II

As described by U.S. FDA — Device Enforcement: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1412-2019
Date of alert
2018-06-27
Country / jurisdiction
Sweden
Risk level
Class II
Notice type
recall
Brand
Elekta Instrument AB
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.
Reported risk: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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