Recall Z-1164-2026 ยท IYE Accelerator, Linear, Medical
Elekta, Inc.
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
| Date | Jan 23, 2026 (initiated Dec 14, 2025) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue and electrical grounding of systems. |
| Root cause | Process control |
| Action | On 12/14/2025, the firm emailed an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" Letter to customer informing them that Elekta has identified a safety issue relating to the modulator discharge rod, where the supplier has been fitting the crimp in the crimp tool back to front. The issue was discovered during production. Note - The discharge rod is used by Field Service Engineers (FSE) when completing service activities on the machine around the HT and RF (High Tension (high voltage) and Radio Frequency) assembly. Instructions to customer: No actions are required to be taken by the Clinical user |
| Quantity | 5391 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Elekta Limited, Jun 11, 2021 |