VitalBeam Radiotherapy Delivery System Version 2 — Class II medical device recall Z-0005-2019
Terminated recall by Varian Medical Systems, reported 2018-10-10, distributed nationwide. Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory t
| Recall number | Z-0005-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Palo Alto, CA, United States |
| Recall initiated | 2018-08-20 |
| Classified | 2018-10-01 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BG, BR, CA, CH, CN, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, HR, IE, IL, IN, IT, JP, KR, LB, MA, NL, NO, NP, NZ, PA, PL, RU, SA, SE, TH, TR, TW |
| Quantity | 4 |
Product
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Reason for recall
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
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-0005-2019. 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.