Elekta Medical Linear Accelerator Component Non-Compliant with Safety Standard
Elekta Inc. is recalling a limited number of Elekta Linacs due to a component non-compliant with safety standards. No reported injuries or illnesses.
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: This is an FDA Class II recall of a radiation therapy device component found non-compliant with IEC 60601 safety standards. Although no illnesses or injuries have been reported, the non-compliance poses a potential risk given the critical nature of radiation therapy equipment.
Plain-English summary
Elekta Inc. is recalling a limited number of Elekta Medical Linear Accelerators (ELMA) across three platforms: Elekta Infinity, Versa HD, and Elekta Synergy. A component within these devices has been found to be non-compliant with IEC 60601, an international safety standard for medical electrical equipment.
Approximately 46 units have been affected and are distributed worldwide. In the United States, affected units were distributed to Arkansas, Indiana, Louisiana, Oklahoma, Tennessee, Virginia, and Washington. International distribution includes Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain, and Libya.
Healthcare facilities and providers who use these devices should contact Elekta Inc. for further instructions regarding the affected serial numbers and platforms. The specific serial numbers and UDI-DI numbers are available through the FDA and the manufacturer.
The recalled product
- Product
- Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
- Manufacturer
- Elekta, Inc.
- Affected units
- 46
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)
- 05060191071512 (Serial Numbers: 156073
- 152223
- 153681)
- b. Versa HD: UDI-DI Number: 05060191071574
- 05060191071529 (Serial Numbers: 156941
- 156989
- 156724
- 156998)
- c. Elekta Synergy: UDI-DI Number: 05060191071550
- 109333
- 109335
- 109336
- 109339
- 109341
- 109342
- 151879
- 152194
- 153038
- 153299
- 153410
Distribution
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