CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
Philips Azurion 3M15 recalled by Philips Medical Systems
Philips Medical Systems Nederland B.v is recalling Philips Azurion 3M15, distributed nationwide in the US. The recall was initiated on 7 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2285-2026
- FDA event ID
- 98977
- Recalling firm
- Philips Medical Systems Nederland B.v, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Dec 2023
- FDA classified
- 1 Jun 2026
- Reported
- 10 Jun 2026
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 7 Dec 2023 | Recall initiated by company | |
| 1 Jun 2026 | Classified by FDA | +907 days |
| 10 Jun 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips Azurion 3M15, Model Numbers: 722064, 722222 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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Philips Azurion 3M15 recalled?
Yes. Philips Medical Systems Nederland B.v recalled Philips Azurion 3M15 on 7 Dec 2023. The recall is Class II and its status is Ongoing. Recall number Z-2285-2026.
Why was it 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.
Which lots are affected?
UDI (01)00884838085282(21)209, (01)00884838099210(21)100, (01)00884838099210(21)254, (01)00884838099210(21)256, (01)00884838099210(21)257, (01)00884838099210(21)265, (01)00884838099210(21)255, (01)00884838099210(21)99, (01)00884838085282(21)260, (01)00884838085282(21)261, (01)00884838099210(21)69, (01)00884838099210(21)12, (01)00884838085282(21)314, (01)00884838085282(21)259, (01)00884838099210(21)15, (01)00884838099210(21)19, (01)00884838099210(21)23, (01)00884838099210(21)17, (01)00884838085282(21)258, (01)00884838099210(21)55, (01)00884838099210(21)45, (01)00884838085282(21)270, (01)00884838099210(21)187, (01)00884838099210(21)223, (01)00884838099210(21)44, (01)00884838099210(21)113, (01)00884838099210(21)112.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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