Philips Allura Imaging Systems Hard Drive Degradation Affects Functionality
Philips Allura fluoroscopic imaging systems may experience hard drive degradation after six years of service, potentially resulting in loss of imaging capability and motorized movement.
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 is a Class II medical device recall with potential for loss of critical functionality in medical imaging systems. No illnesses or injuries are reported in the source text, and the hazard is risk-based rather than confirmed to have caused documented harm. This falls under the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems has issued a recall for Allura X-ray imaging systems (multiple models) due to hard drive degradation in the system PCs that may occur as the devices age, particularly beyond six years of operation.
The affected hard drives may show decreased performance over time. Depending on the specific system, this degradation could result in loss of imaging functionality, loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
This recall affects Allura systems distributed worldwide, including across the United States and numerous international locations. Healthcare facilities and imaging centers using affected systems should contact Philips for guidance on hard drive replacement or other mitigation measures to prevent loss of critical imaging capabilities.
The recalled product
- Product
- Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allur
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- hard-drive-failure
- loss-of-imaging
- equipment-malfunction
- data-loss
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 (20)
- 1. Allura Xper FD10
- Model: 722003
- UDI-DI: N/A
- Serial Numbers: 445
- 1555
- 1114
- 1529
- 472
- 1349
- 1594
- 1311
- 1472
- 1187
- 1700
- 1031
- 912
- 913
- 940
- 285
- 1637
Distribution
Distributed nationwide across the United States.
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