Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Syn
FDA device recall Z-1665-2023 · posted 2023-05-30 · Open, Classified
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
- Action taken
- Elekta notified customers, via email, on 05/05/2023. Customers were instructed that Elekta will contact each impacted customer to perform an onsite inspection of the power supply unit and replace as needed. Customers were asked to complete and return the Acknowledgement Form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- IYE
- Quantity 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,
- Date initiated
- 2023-05-05
- Date posted
- 2023-05-30
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD (K210500) | Elekta Limited | 2021-06-11 |