Philips Allura X-ray Systems Deaeration Hose Degradation Recall
Deaeration hoses in Philips Allura X-ray tube cooling units may degrade and leak oil, reducing cooling performance. Affected units were manufactured between February 2016 and May 2020.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is functional degradation (reduced cooling performance with automatic fallback to low-dose mode) rather than a direct safety threat. The device includes a built-in safety response to the condition.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Allura X-ray systems equipped with type CU3101 X-ray tube cooling units manufactured between February 2016 and May 2020. The deaeration hose in these cooling units may degrade over time, potentially resulting in oil leakage.
When oil leaks from the cooling unit, the system's cooling performance is compromised. If oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays a message indicating "Tube cooler problem." This condition cannot be resolved by restarting the system.
Affected units were distributed domestically across the United States and internationally to numerous countries. A total of 3,314 units are involved in this recall (816 in the US and 2,498 units outside the US).
Customers who have affected Allura systems should contact Philips Medical Systems for guidance on inspection and potential remediation options.
The recalled product
- Product
- Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 72
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- oil-leakage
- cooling-system-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 (20)
- Code Information: Allura: 1. Allura Xper FD10C
- Model: 722001
- UDI-DI: N/A
- Serial Numbers: 170
- 242
- 267
- 142
- 206
- 316
- 9
- 306
- 103
- 33
- 220
- 2. Allura Xper FD10F
- Model: 722002
- Serial Numbers: 0
- 81
- 47
- 3. Allura Xper FD10
Distribution
Distributed nationwide across the United States.