Philips Azurion 5M20, Model Numbers: 722228 with Software release recall: During the device phase of Roadmap Pro, a user may experience a dark image
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2287-2026
- Published
- June 10, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Philips Medical Systems Nederland B.v.
- Product type
- Medical devices
- Units affected
- 51 units
- Distribution
- Nationwide
- Made in
- Netherlands
- Lot / code info
- UDI (01)00884838099234(21)67, (01)00884838099234(21)49, (01)00884838099234(21)10, (01)00884838099234(21)36, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)328, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)61, (01)00884838099234(21)204, (01)00884838099234(21)273, (01)00884838099234(21)76, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)189, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)38, (01)00884838099234(21)87, (01)00884838099234(21)128, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)181, (01)00884838099234(21)177, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)79, (01)00884838099234(21)80, (01)00884838099234(21)157, (01)00884838099234(21)24, (01)00884838099234(21)187, (01)00884838099234(21)26, (01)00884838099234(21)29, (01)00884838099234(21)122, (01)00884838099234(21)127, (01)00884838099234(21)6, (01)00884838099234(21)123, (01)00884838099234(21)124, (01)00884838099234(21)92, (01)00884838099234(21)215, (01)00884838099234(21)91, (01)00884838099234(21)205, (01)00884838099234(21)20, (01)00884838099234(21)37a.
- UPC codes
- 00884838099234
Products covered by this recall
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Check your product
The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00884838099234
Model or item number
On the rating label, the box or the instruction sheet.
- R2.2.1
- R2.2.3
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Philips Medical Systems Nederland B.v. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Veenpluis 6, Best
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Philips Medical Systems Nederland B.v. medical devices recalled?
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the…
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00884838099234; model number R2.2.1, R2.2.3. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · 2 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD. Model Numbers: 722026 recall: Firmware issue potentially leading to loss of geometry movements
Firmware issue potentially leading to loss of geometry movements.
-
Class II · 2 months ago
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232 recall: Two software related issues: 1) Potential image quality degradation
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate…
-
Class II · 2 months ago
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067 recall: Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural…
-
Class II · 2 months ago
Philips Allura, Cardio Vascular-Allura Centron recall: Potential Loss of imaging functionality, loss of motorized movement
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
-
Class II · 2 months ago
Philips Azurion under the following System Descriptions recall: Potential Loss of imaging functionality, loss of motorized movement
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
-
Class II · 2 months ago
Philips Allura under the following System Descriptions recall: Potential Loss of imaging functionality, loss of motorized movement
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.