Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment… — Class II medical device recall Z-1103-2013
Terminated recall by Integra LifeSciences Corp., reported 2013-04-24, distributed in ID, IL, LA, MA, NJ, NY, OH, PA…. Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam
| Recall number | Z-1103-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2012-12-10 |
| Classified | 2013-04-12 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-08-01 |
| Distributed | ID, IL, LA, MA, NJ, NY, OH, PA, SD |
| Reason classes | software |
Product
Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
Reason for recall
Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
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-1103-2013. 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.