CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
Philips Allura, Cardio Vascular-Allura Centron recalled
Philips Medical Systems Nederland B.v is recalling Philips Allura, Cardio Vascular-Allura Centron, distributed nationwide in the US. The recall was initiated on 17 Jun 2026 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-2893-2026
- FDA event ID
- 99313
- Recalling firm
- Philips Medical Systems Nederland B.v, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2026
- FDA classified
- 5 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jun 2026 | Recall initiated by company | |
| 5 Aug 2026 | Classified by FDA | +49 days |
| 12 Aug 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Product as listed by the FDA
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Philips Allura, Cardio Vascular-Allura Centron recalled?
Yes. Philips Medical Systems Nederland B.v recalled Philips Allura, Cardio Vascular-Allura Centron on 17 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2893-2026.
Why was it recalled?
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Which lots are affected?
Model Number: 722400. 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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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