Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Reported: October 20, 2021 Initiated: September 28, 2021 #Z-0115-2022
Product Description
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
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.
Details
- Recalling Firm
- ELEKTA SOLUTIONS AB
- Units Affected
- 2 in the U.S.
- Distribution
- Distribution was to ND and NC. There was no military/government distribution.
- Location
- Stockholm, N/A
Frequently Asked Questions
What product was recalled? ▼
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.. Recalled by ELEKTA SOLUTIONS AB. Units affected: 2 in the U.S..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0115-2022.
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