Z-1895-2024 Class II Ongoing
FDA device recall Z-1895-2024 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on May 16, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1 unit (US).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 5, 2024
- Initiation Date
- May 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit (US)
Product Description
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
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.
Distribution Pattern
Domestic: OK International: India, Spain, U.A.E.
Code Information
Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1895-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026