GammaPlan software recalled over plans that may irradiate the wrong location
Elekta is recalling Leksell GammaPlan versions 11.3 and 11.4 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the error may produce a plan that irradiates the incorrect patient location, and no injuries are reported.
Plain-English summary
Leksell GammaPlan, a radionuclide RT treatment planning system, software versions 11.3 and 11.4, is being recalled by Elekta, Inc. The record describes Leksell GammaPlan as a computer-based system designed for Leksell Gamma Knife treatment planning.
The record states the recall is due to an error when defining a new stereotactic reference, where users fail to first change an already defined obsolete reference to a pre-plan reference. The record states this may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
The record's quantity field reads 'N/A'. The recall covers lot codes 07340048311878 (LGP 11.3) and 07340201502136 (LGP 11.4). Distribution was worldwide, including nationwide in the United States across the states listed in the enforcement record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Sites should follow Elekta's instructions.
The recalled product
- Product
- Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
- Manufacturer
- Elekta, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Elekta, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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