Philips Allura Xper X-ray System Memory Modules May Stop Functioning
Philips Allura Xper fluoroscopic X-ray systems may experience memory module failures that cause the system to stop functioning and prevent imaging. This malfunction could delay critical medical 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: No adverse events or injuries have been reported. This is a Class II recall where the primary hazard is potential system failure with no documented patient harm, meeting the criteria for Score 3 per FDA severity guidelines.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling Philips Allura Xper Interventional Fluoroscopic X-ray Systems due to potential failures in the Dual In-line Memory Modules (DIMMs) used in these systems.
The DIMMs may not perform as intended, which could cause the imaging system to stop functioning. When this occurs, X-ray imaging becomes impossible, preventing the medical team from performing planned imaging procedures and resulting in procedure delays.
The recall affects approximately 1,681 systems distributed in the United States and 3,819 systems distributed internationally across more than 80 countries. Affected systems include multiple Allura Xper models with various model numbers, including the FD10, FD10/10, FD10C, FD20, FD20 Biplane, and FD20/20 variants.
If you operate an affected Philips Allura Xper system, contact Philips Medical Systems Nederland B.V. immediately for instructions on how to proceed. Do not use the equipment if you suspect DIMM failure or if imaging functions are not operating as expected.
The recalled product
- Product
- Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- device-malfunction
- imaging-failure
- procedure-delay
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 (7)
- Allura Xper FD10/10 722005 - no UDI Serial Numbers 261 329 344 456 49 523 63
- 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 FD20/20 OR Table 722039 - No UDI Serial Number 3
Distribution
Distributed nationwide across the United States.
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