Elekta Unity — Class II medical device recall Z-0706-2019
Completed recall by Elekta Limited, reported 2019-01-16, distributed in TX, WI. In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and wea
| Recall number | Z-0706-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Limited, Crawley, United Kingdom |
| Recall initiated | 2019-01-04 |
| Classified | 2019-01-09 |
| Reported by FDA | 2019-01-16 |
| Distributed | TX, WI |
| Countries outside the US | DE, DK, GB, NL |
| Quantity | 2 units |
| Reason classes | packaging |
| Serial numbers | 1536549 |
Product
Elekta Unity
Reason for recall
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
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-0706-2019. 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.