CLASS II Device recall · Reported 7 Aug 2019 · FDA Enforcement Report
Azurion lnterventional Fluoroscopic X-ray System recalled
Philips Medical Systems Nederlands is recalling Azurion lnterventional Fluoroscopic X-ray System, distributed nationwide in the US. The recall was initiated on 30 Nov 2018 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-1997-2019
- FDA event ID
- 83366
- Recalling firm
- Philips Medical Systems Nederlands, Best, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Nov 2018
- FDA classified
- 30 Jul 2019
- Reported
- 7 Aug 2019
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 30 Nov 2018 | Recall initiated by company | |
| 30 Jul 2019 | Classified by FDA | +242 days |
| 7 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
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
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Which lots are affected?
software version R1.2
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems Nederlands
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Allura Xper System: Interventional Fluoroscopic recalled | Philips Medical Systems Nederlands | Device Malfunction | 10 states |
| Device | CLASS II | Ingenia Ambition S (781359), Ingenia Ambition X recalled | Philips Medical Systems Nederlands | Other | FL |
| Device | CLASS II | Foot Switches used with the following systems recalled | Philips Medical Systems Nederlands | Other | Nationwide |
| Device | CLASS II | Foot Switches used with Philips MultiDiagnost Eleva recalled | Philips Medical Systems Nederlands | Other | Nationwide |
| Device | CLASS II | Intera 1.5T High Performance recalled by Philips Medical Systems | Philips Medical Systems Nederlands | Other | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |