Azurion systems with software release R2 — Class II medical device recall Z-0734-2022
Completed recall by Philips Healthcare, reported 2022-03-30, distributed nationwide. In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add
| Recall number | Z-0734-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Philips Healthcare, Andover, MA, United States |
| Recall initiated | 2021-05-26 |
| Classified | 2022-03-23 |
| Reported by FDA | 2022-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 69 systems |
| Reason classes | software |
Product
Azurion systems with software release R2.0.x
Reason for recall
In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.
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-0734-2022. 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.