Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Check against the official notice below — it lists the full affected range.
Elekta Solutions AB is recalling three models of medical linear accelerators (radiation therapy machines) used in medical facilities: the Elekta Harmony Pro, Elekta Infinity, and Elekta Versa HD. The recall affects a total of two units in the United States that were distributed to facilities in North Dakota and North Carolina. The machines were recalled because a component called Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and the protective tube surrounding it may not adequately contain the ejected matter from the failed diode.
The specific units affected are the Elekta Harmony Pro (Serial #441009), Elekta Infinity (Serial #156645), and three Elekta Versa HD units (Serial #156646, #156477, and #156648). The source document does not specify a remedy or what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Distribution was to ND and NC. There was no military/government distribution. Quantity: 2 in the U.S. Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.