Laksell Gamma Knife Perfexion — Class II medical device recall Z-0152-2015
Terminated recall by Elekta, Inc., reported 2014-11-05, distributed nationwide. Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorl
| Recall number | Z-0152-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2014-10-06 |
| Classified | 2014-10-30 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2021-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CO, CZ, DE, EG, ES, FR, GB, GR, HK, ID, IN, IT, JP, KR, MA, MX, NO, PL, PT, RU, SA, SE, TR, TW |
| Quantity | 181 |
| Serial numbers | 6002, 6003, 6004, 6005, 6006, 6007, 6008, 6009, 6010, 6011, 6012, 6013, 6014, 6015, 6016, 6017, 6018, 6019, 6020, 6021, 6022, 6023, 6024, 6025, 6026 and 156 more |
Product
Laksell Gamma Knife Perfexion
Reason for recall
Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0152-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.