FDAFDA · Food and drugs·Recall number Z-1895-2024
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Published June 5, 2024 · Recall initiated: May 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- Domestic: OK International: India, Spain, U.A.E.
- Lot
- Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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