Elekta Leksell Gamma Knife Icon Recall for Electrical Safety Risk
Elekta is recalling two Leksell Gamma Knife Icon units due to a potential electrical safety risk for technicians performing maintenance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (electrical safety) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Elekta, Inc. is recalling two Leksell Gamma Knife Icon teletherapy devices. These devices are intended for stereotactic irradiation of head structures, including various tumors and benign diseases. The recall is limited to units distributed in New York and Pennsylvania.
The recall is issued because if the gantry module is replaced after the original installation, the configuration settings may be missing. This issue creates an identified risk regarding electrical safety for technicians who perform maintenance on the X-ray generator.
Affected units have serial numbers 6018, 6047, 6090, 6094, 6171, and 8018. The source text does not specify further actions for consumers or the number of affected patients.
The recalled product
- Product
- Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory…
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 2
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 (6)
- Serial Numbers 6018
- 6047
- 6090
- 6094
- 6171
- 8018
Distribution
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