Philips Allura Xper X-ray systems disk bay component may malfunction
Philips has recalled certain Allura Xper interventional X-ray systems because the disk bay component may fail, potentially preventing system operation and imaging procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a functional failure that could prevent system operation and imaging procedures. Although the failure poses a significant risk to patient care delivery and procedure delays, no illnesses or injuries have been reported to date.
Plain-English summary
Philips Medical Systems Nederland B.V. has recalled certain Allura Xper Interventional Fluoroscopic X-ray Systems. The recall affects the Disk Bay component of the personal computer systems used in these imaging devices, including Imaging Processing PC, Host PC, and FlexVision PC configurations. Multiple models of the Allura Xper FD-series are affected.
The disk bay component may not perform as intended. If affected, the system may stop functioning entirely and imaging procedures may not be possible. This could result in significant delays to patient care procedures that depend on this imaging system.
Approximately 13,133 systems have been distributed globally, including 3,408 units in the United States and 9,725 units internationally. The systems are in use across all U.S. states and in numerous countries worldwide.
The recalled product
- Product
- Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- system-failure
- imaging-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 722010 - UDI-DI 00884838059030 or 00884838059191
- Allura Xper FD10 OR Table 722022 - No UDI Serial Number 6
- Allura Xper FD10C 722001 - no UDI Serial Numbers 213 273
- 722012 - UDI-DI 00884838059054
- 00884838059191
- 722028 - UDI-DI 00884838054202
- Allura Xper FD20 Biplane OR Table 722025 - no UDI Serial Numbers 2 3
- Allura Xper FD20/15 OR Table 722059 - UDI-DI 00884838059122 Serial Numbers 33 7
- Allura Xper FD20/20 OR Table 722039 - No UDI Serial Number 3
Distribution
Distributed nationwide across the United States.
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