[pending] Allura Xper FD20/20; Model Number: 722038;
Pending LLM rewrite. Source: FDA_DEVICE Z-1077-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
The recalled product
- Product
- Allura Xper FD20/20; Model Number: 722038;
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Category
- Medical Device — Devices
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 (11)
- Model Number: 722038
- System Product Name: Allura Xper FD20/20
- UDI-DI: 00884838054226
- Serial Numbers: 11
- 117
- 110
- 134
- 64
- 90
- 124
- 72
Distribution
Distributed nationwide across the United States.
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