FDA Device recall Z-1581-2026
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta…
- FDA Device
- Class II
- ongoing
- Published 2026-03-25
On 2026-03-25 the FDA classified a Class II recall of Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta… by Elekta, citing due to adapter not being properly aligned or locked in place.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1581-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-18 |
| Published | 2026-03-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Elekta |
| Distribution | US |
Product
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Reason
Due to adapter not being properly aligned or locked in place.
Identifiers
| code_info | Lot Code: 07340048303019 (Perfexion) Product and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6…Lot Code: 07340048303019 (Perfexion) Product and Serial Numbers: LGK Perfexion/11868-004/6002 LGK Perfexion/12214-003/6007 LGK Perfexion/10567-026/6011 LGK Perfexion/10567-024/6014 LGK Perfexion/12451-001/6019 LGK Perfexion/10064-008/6021 LGK Perfexion/18630-001/6031 LGK Perfexion/11813-003/6034 LGK Perfexion/11007-005/6035 LGK Perfexion/10908-003/6045 LGK Perfexion/13337-LGK001/6052 LGK Perfexion/10762-005/6057 LGK Perfexion/11550-001/6065 LGK Perfexion/14878-003/6067 LGK Perfexion/11792-005/6077 LGK Perfexion/10356-007/6079 LGK Perfexion/10924-001/6089 LGK Perfexion/15045-LGK001/6091 LGK Perfexion/11848-003/6095 LGK Perfexion/12236-006/6097 LGK Perfexion/13558-001/6099 LGK Perfexion/20364-001/6103 LGK Perfexion/10848-LGK001/6108 LGK Perfexion/11390-LGK001/6109 LGK Perfexion/30002718-001/6113 LGK Perfexion/11433-LGK001/6116 LGK Perfexion/10643-005/6117 LGK Perfexion/11990-LGK001/6118 LGK Perfexion/12620-002/6120 LGK Perfexion/17322-001/6121 LGK Perfexion/105528-001/6122 LGK Perfexion/ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Elekta
- Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Flet…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced…
FDA Device · Class II · 2026-07-15 · Elekta - Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for c…
FDA Device · Class II · 2026-07-15 · Elekta - MOSAIQ Oncology Information System
FDA Device · Class II · 2026-06-17 · Elekta - Brand Name: Leksell Vantage Arc System REF: 1053958
FDA Device · Class II · 2026-05-06 · Elekta
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1581-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.