CLASS II ONGOING Device recall · Reported 5 Jun 2024 · FDA Enforcement Report
Philips Allura Xper FD10 system with an ADN7NT patient table recalled
Philips Medical Systems Nederland B.v is recalling Philips Allura Xper FD10 system with an ADN7NT patient table, distributed nationwide in the US. The recall was initiated on 16 May 2024 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-1896-2024
- FDA event ID
- 94647
- Recalling firm
- Philips Medical Systems Nederland B.v, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 May 2024
- FDA classified
- 24 May 2024
- Reported
- 5 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 16 May 2024 | Recall initiated by company | |
| 24 May 2024 | Classified by FDA | +8 days |
| 5 Jun 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
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 Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Where it was distributed
Domestic: OK International: India, Spain, U.A.E.
Questions about this recall
Is Philips Allura Xper FD10 system with an ADN7NT patient table recalled?
Yes. Philips Medical Systems Nederland B.v recalled Philips Allura Xper FD10 system with an ADN7NT patient table on 16 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-1896-2024.
Why was it recalled?
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
Which lots are affected?
Product number: 722010, UDI/DI: 00884838059030; Serial Numbers: 774, 909, 526.
Where was it sold?
Domestic: OK International: India, Spain, U.A.E.
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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