Elekta Linear Accelerators Recalled for Default Value Reset Issues
Elekta, Inc. is recalling SL & SLi Series linear accelerators because customers are resetting default values outside recommended factory settings.
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 high-risk medical device (linear accelerator) where a defect could lead to harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Elekta, Inc. is recalling 449 units of the SL & SLi Series (Mod 15/18/20/25) Linear Accelerators. These devices are used for radiation therapy treatments of malignant neoplastic diseases.
The recall is being conducted because customers are resetting the default values outside of recommended factory settings. This action may compromise the device's intended performance and safety parameters.
The affected units were distributed worldwide, including in the United States and numerous international countries. Consumers and healthcare facilities should contact Elekta, Inc. for instructions on how to address this issue.
The recalled product
- Product
- SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
- Manufacturer
- Elekta, Inc.
- Hazard
- Affected units
- 449
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 (20)
- 105285
- 105445
- 105305
- 105532
- 105366
- 105403
- 105265
- 105492
- 105273
- 105186
- 105494
- 105481
- 105395
- 105326
- 105467
- 105392
- 105204
- 105382
- 105093
- 105521
Distribution
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