FDA Device recall Z-0886-2022
Azurion systems with software release R1.x
- FDA Device
- Class II
- ongoing
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Azurion systems with software release R1.x by Philips Medical Systems Nederland B V, citing 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 selecte….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0886-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-26 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Azurion systems with software release R1.x
Reason
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.
Identifiers
| code_info | software release R1.x |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0886-2022%22
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