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
USBrand 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
Recalling Firm: Elekta, Inc.
Reason for Recall / Hazard
Due to a manufacturing issue and electrical grounding of systems.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 97958 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| Address 2 | N/A |
| Code info | Lot Code: 05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo |
| Postal code | 30346-1227 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 5391 |
| Reason for recall | Due to a manufacturing issue and electrical grounding of systems. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251214 |
| Initial firm notification | Letter |
| Center classification date | 20260123 |
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Overview
- Recalling FirmElekta, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide
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🚨 SAFETY ALERT: 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 Check if your household is affected: https://therecallfile.com/recalls/brand-name-elekta-medical-linear-accelerator-product-name-elekta-syner/FDA-Z-1164-2026
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