HIGH

Philips Recalls Allura Xper FD10C Systems Over Electrical Hazard

Philips recalled 38 Allura Xper FD10C systems on December 15, 2025, due to a potential electrical hazard. The drip tray beneath the cooling unit may not have been properly installed, risking coolant contact with electrical components. This could lead to electrical shorts and system shutdowns.

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the Allura Xper FD10C, model number 722001. It was distributed worldwide, including the United States and several countries across Europe, Asia, and South America. Exact serial numbers affected include 166, 181, 153, 274, 296, 267, 206, 247, 161, 282, 213, 284, 103, 199, 129, 95, and 299.

The Hazard

If the drip tray is missing or improperly installed, coolant may leak onto electrical components. This poses a risk of electrical short-circuits, potentially triggering system fuses and causing the equipment to shut down.

Reported Incidents

Philips has not reported any incidents or injuries related to this recall. However, the potential for electrical shorts represents a high risk to patient safety.

What to Do

Stop using the Allura Xper FD10C system immediately. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for further instructions.

Contact Information

For more details, reach out to Philips at the official website or refer to the recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1062-2026.

Key Facts

  • Recall date: December 15, 2025
  • 38 units recalled worldwide
  • Potential electrical hazard due to coolant leak
  • Immediate stop-use recommended
  • Contact manufacturer for next steps

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product Details

Model Numbers
Model Number: 722001
System Product Name: Allura Xper FD10C
UDI-DI: N/A
Serial Numbers: 166
181
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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