Lower riskMedical device recall · FDA · Published May 26, 2021
Philips Azurion Systems Software R1.x Recall: Incorrect Patient Type Risk
Philips recalls Azurion systems with software release R1.x due to a defect causing incorrect patient type selection during studies, potentially affecting dose control. Affected units may need correction.
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.
Take action
Contact the company
📍Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands
“Philips Azurion Systems Software R1.x Recall: Incorrect Patient Type Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62484-philips-azurion-systems-software-r1-x-recall-incorrect-patient-type. Based on FDA recall #Z-0886-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0886-2022%22&limit=1).
The FDA announced on May 26, 2021, that Philips Medical Systems Nederland B.V. is recalling Azurion systems with software release R1.x due to a software defect. The hazard involves inadvertent changes to patient types during studies, which alters dose control technique factors without user notification.
How to tell if you have it
Brand: Philips
Product: Azurion systems
Software release: R1.x
The hazard
According to the FDA, when a user initiates a study by pressing Start Procedure, the Patient Type changes inadvertently to a different type than selected. This incorrect patient type changes the technique factors used by the system without notification to the user.
Context
GovInfoNow's records show Philips Medical Systems Nederland B.V. has 58 other recalls on record since December 2, 2021. Recent recalls include a July 16, 2026 recall for Azurion R2.2.10 Systems regarding potential image quality degradation and a June 29, 2026 recall for a firmware issue potentially leading to loss of geometry movements. Other recent recalls of similar products include the Philips IQon Spectral CT Software 4.7.7.x Recall (August 7, 2026) and the Elekta Leksell GammaPlan 11.1 Software Recall (December 12, 2025).
How to tell if you have this one
Check for Philips Azurion systems with software release R1.x. The software version is listed in the system's settings or documentation.
Brand
Philips
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version in the system settings or documentation to confirm if it is R1.x.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide and Worldwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0886-2022 (May 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0886-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.