Food, drugs, devices › PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Device recall: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Versio
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (Best) initiated this device recall on 16 Jul 2026; FDA lists 1 product record under event 99423, classified Class II.
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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. 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, Netherlands.
Reason for recall
"Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications"
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2932-2026 | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system | 2016 units | Class II | Ongoing | 19 Aug 2026 |
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: "Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications"
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: "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.