A recall caused by the software, not the machine — the device records about things that run (Philips Azurion, 10,872 units)
Two issues were identified in software version R2.2.10 of the Philips Azurion interventional fluoroscopic X-ray system used in catheter procedures: image quality may degrade, and geometry movements may be lost. Both may lead to delay of therapy and procedural complications. The recall covers 10,872 units worldwide.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- ReasonTwo software related issues affecting Azurion R2.2.10 Systems: 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
- DistributionWorldwide
- Recall initiated2026-07-16
Key points
- The product is the Philips Azurion interventional fluoroscopic X-ray system running software version R2.2.10 — 10,872 units distributed worldwide.
- Two issues: potential image quality degradation (delay of therapy, procedural complications, inappropriate treatment) and potential loss of geometry movements (delay of therapy, procedural complications).
- The subject is a software version rather than the hardware, so the response takes the form of distributing an update.
- Classification Class II; firm-initiated on 2026-07-16 and reported on 2026-08-19. Country of manufacture is the Netherlands.
- Of the 1,408 recall records this site holds as of 2026-08-28, 26 — 1.8 percent — cite software in the reason.
- Of the 779 device records this site holds as of 2026-09-01, 26 name software, 22 a display and 10 a battery.
1A recall that collects nothing
The word recall calls to mind pulling product back off the market. What is at issue here is not the hardware but a particular version of the software running on it. An angiography system is a large installed machine in a hospital, and withdrawing it is not a realistic response. Recalls arising from software are generally carried out as the distribution and installation of an update. The regulatory category is the same; what happens on the ground is not.
2Degraded images and a gantry that stops moving
The two issues in the record differ in nature. One is degradation of image quality, which presents as being able to see while seeing less well, and is easy to miss. The other is loss of geometry movements, which presents unmistakably as something not moving. Angiography involves advancing a catheter through vessels while watching fluoroscopic images, so both the image and the angle of the gantry are needed in the moment.
The record states that either issue may lead to delay of therapy and procedural complications.
3Software appears in 26 of 1,408 records
Of the 1,408 FDA recall records this site holds as of 2026-08-28, 26 — 1.8 percent — cite software in the reason. Most of the 779 device recalls describe physical events: broken parts, leaks, defective packaging, wrong labels. Yet medical devices depend on software more each year, so this figure is not the share of recalls actually caused by software; it is how often software is named explicitly as the reason. When the update is expected to complete is not part of this record.
4The device records about things that run
Of the 779 device records this site holds as of 2026-09-01, 26 name software in the reason for recall, 22 name a display and 10 name a battery.
None of these is necessarily settled by swapping a broken part. Software can be repaired by an update with the device left in place, yet the affected units cannot be identified without a record of which version each one carries. The device as an object and the system running inside it have to be handled separately in a recall.
Why it matters
As medical devices lean further on software, recalls shift from a logistics problem to an update-distribution problem. For installed systems, how to operate until the update lands becomes the practical question, and a large installed base translates directly into coordination load. The same word covers responses of quite different kinds.
FAQ
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Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2931-2026