Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Reported: June 7, 2023 Initiated: May 5, 2023 #Z-1665-2023
Product Description
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Reason for Recall
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 46 units
- Distribution
- Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA. International distribution to Belgium, Canada, Chile, China, France, Germany, India, Iraq, Italy, Jordan, Libyan Arab Jamahiriya, Mauritius, Mexico, Morocco, Poland, Russian Federation, Spain.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy. Recalled by Elekta, Inc.. Units affected: 46 units.
Why was this product recalled? ▼
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 7, 2023. Severity: Moderate. Recall number: Z-1665-2023.
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