Elekta Medical Linear Accelerator Diode Component Destructive Failure Risk
Elekta Medical Linear Accelerators may experience destructive diode failure with risk of ejected matter. Service personnel could be injured during component removal.
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 a Class II recall involving a risk-of-harm product—destructive component failure with potential ejection of matter—but with no reported injuries. Risk-of-harm products without reported injury meet the criteria for High severity (score 3).
Plain-English summary
Elekta, Inc. is recalling approximately 4,405 units of the Elekta Medical Linear Accelerator (EMLA) in five configurations: Elekta Precise Digital Accelerator, Elekta Harmony, Elekta Synergy, Elekta Infinity, and Versa HD.
The Diode D1 component in the Modulator can fail in a destructive manner when removed from the machine. The protective tube surrounding the diode may fail to contain ejected matter, creating a risk of injury to service personnel during maintenance or component removal operations.
The affected units were distributed nationwide in the United States and internationally to over 80 countries. This is a Class II FDA recall affecting facilities operating these devices.
The recalled product
- Product
- Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Precise Digital Accelerator; b. Elekta Harmony; c. Elekta Synergy; d. Elekta Infinity; e. Versa HD
- Manufacturer
- Elekta, Inc.
- Affected units
- 4,405
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 (19)
- a. Elekta Precise Digital Accelerator - UDI GTIN Number: 5060191071017
- Model Numbers: XRT 0601 (NFB)
- XRT 0611 (FB)
- All Serial Numbers
- b. Elekta Harmony - UDI GTIN Number: 05060191071581
- Model Numbers: XRT 2201 (NFB)
- c. Elekta Synergy - UDI GTIN Number: 05060191071550
- Model Numbers: XRT 0621 (NFB)
- XRT 0631 (FB)
- d. Elekta Infinity - UDI GTIN Number: 05060191071543
- 05060191071512
- Model Numbers: XRT 0511 (NFB & MLCi2)
- XRT 0521 (FB & MLCi2)
- XRT 0531 (NFB & Agility)
- XRT 0541 (FB & Agility)
- e. Versa HD - UDI GTIN Number: 05060191071574
- 05060191071529
- Model Numbers: XRT 2121 (NFB)
- XRT 2131 (FB)
Distribution
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