Elekta Medical Linear Accelerator Diode Failure Risk During Maintenance
Elekta medical linear accelerators may have a defective diode that could fail destructively when removed, with risk of ejected debris. No injuries have been reported.
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 for a medical device with a potential hazard (destructive diode failure with possible debris ejection). Per the severity rubric, risk-of-harm products without reported injury are rated High (3).
Plain-English summary
Elekta medical linear accelerators (EMLA)—specifically the Harmony Pro, Infinity, and Versa HD models—are the subject of this recall. These devices are used in radiation therapy.
The issue involves Diode D1 in the Modulator. When the diode is removed, there is a risk that it may fail in a destructive manner. The protective tube surrounding the diode may fail to contain the ejected matter.
Two units of these models were distributed in the United States, in North Dakota and North Carolina. No illnesses or injuries have been reported.
Affected facilities should contact the manufacturer, Elekta Solutions AB, regarding appropriate corrective measures.
The recalled product
- Product
- Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
- Manufacturer
- ELEKTA SOLUTIONS AB
- 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 (11)
- Elekta Harmony Pro
- Serial #441009
- UDI (01) 05060191071604
- Elekta Infinity
- Serial #156645
- UDI (01) 05060191071543
- and Elekta Versa HD
- Serial #156646
- #156477
- and #156648
- UDI (01) 05060191071574
Distribution
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