Device product
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Z-0115-2022
Product summary
- Event
- Event 88771
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 in the U.S.
- Official record key
device-enforcement:Z-0115-2022
Official wording
Reason: There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
Code information: 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 pattern: Distribution was to ND and NC. There was no military/government distribution.
Derived failure modes
-
Unknown
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.