Philips Allura Imaging Systems May Shut Down During Power Loss Events
Philips Allura medical imaging systems configured with certain power supplies may shut down or fail to start if power is lost, potentially disrupting patient care. Affected facilities should contact Philips to verify configuration and arrange remediation.
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 recall addresses a functional failure risk in critical medical imaging systems without reported injuries. Per the rubric, potential harm to medical devices where injury has not yet been reported is scored as High (3).
Plain-English summary
Philips Allura medical imaging systems (fluoroscopy and interventional radiology equipment) configured with 1 Phase Uninterruptible Power Supply (UPS) have been recalled due to a potential malfunction. These systems may shut down or fail to start if the facility experiences a power loss or interruption. This configuration affects the systems' reliability and availability during critical medical procedures.
The recall affects approximately 1,006 Philips Allura units distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, Latin America, and other regions. Multiple model variants are affected, including Model Numbers 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722023, 722026, 722027, 722028, 722029, 722035, 722038, 722058, and 722059. Specific serial numbers for each model have been identified by Philips.
Healthcare facilities that operate Philips Allura systems should contact Philips Medical Systems Nederland B.V. immediately to verify their system's UPS configuration and determine if they possess an affected unit. Philips is working with facilities to provide remediation solutions and technical support for affected systems.
The recalled product
- Product
- Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Hazard
- unexpected-shutdown
- power-failure
- device-malfunction
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. Model Number/System Code (UDI)
- Serial Numbers: 722003 (No UDI)
- 1225
- 789
- 1138
- 445
- 740
- 152
- 1411. 2. Model Number/System Code (UDI)
- Serial Numbers: 722005 (No UDI)
- 35. 3. Model Number/System Code (UDI)
- Serial Numbers: 722006 (No UDI)
- 168
- 2198
- 2184
- 2606
- 195
- 161
- 1956
- 2256
Distribution
Distributed nationwide across the United States.
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