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RecallWatchMedical Device Safety
Root cause

Other

An FDA-recorded root-cause determination. The FDA lists 61 recalls with this root cause since 2025, 31 of them Class I (most serious). Most recent report: Jan 21, 2026.

Class I: 31Class II: 30
Class IIOngoingZ-1070-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1068-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1064-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1065-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1067-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1062-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Product Name: Allura Xper FD10C

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1076-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/10

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1074-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1069-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1063-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10F

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1075-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026
Class IIOngoingZ-1077-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/20

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 document…

  • Interventional Fluoroscopic X-Ray System
  • Other
PHILIPS MEDICAL SYSTEM…Jan 21, 2026

Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.