Food, drugs, devices › PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Device recall: Azurion systems with software release R1.x
FDA enforcement event 89964 is a device recall by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. of Best, N/A, initiated 26 May 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: fda mandated. PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 59 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best, N/A, Netherlands.
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…"
Distribution
"US Nationwide and Worldwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0886-2022 | Azurion systems with software release R1.x | 722 systems | Class II | Ongoing | 11 May 2022 |
Context
Other enforcement events for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
All 59 events for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide and Worldwide Distribution"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.