Company: Elekta Inc.
Date of Enforcement Report 6/17/2015
Class lI:
PRODUCT
Leksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Recall Number Z-1719-2015
REASON
Memory can become corrupted when creating a fused study via drag & drop in Leksell GammaPlan 10.2.
RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 6/1/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
10
DISTRIBUTION
Nationwide and Internationally
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