Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reported: May 29, 2019 Initiated: June 27, 2018 #Z-1412-2019
Product Description
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reason for Recall
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Details
- Recalling Firm
- Elekta Instrument AB
- Units Affected
- 52 devices
- 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.
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.. Recalled by Elekta Instrument AB. Units affected: 52 devices.
Why was this product recalled? ▼
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1412-2019.
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