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RecallWatchMedical Device Safety
Device type

Stationary X-Ray System recalls

The FDA has posted 10 enforcement recalls of stationary x-ray system devices since 2025, none of them Class I (most serious). Most recent report: Feb 11, 2026.

Class II: 10

Who is recalling these devices

Class IIOngoingZ-1299-2026

FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if…

  • Stationary X-Ray System
  • Process control
FUJIFILM Healthcare Am…MAFeb 11, 2026
Class IIOngoingZ-0466-2026

Philips Medical Systems DMC GmbH recalls Radiography 7300 C

Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e.…

  • Stationary X-Ray System
  • Device Design
Philips Medical System…Nov 19, 2025
Class IIOngoingZ-0044-2026

FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated to…

  • Stationary X-Ray System
  • Device Design
FUJIFILM Healthcare Am…MAOct 15, 2025
Class IIOngoingZ-1046-2025

GE Medical Systems, LLC recalls Optima XR646 HD. X-Ray imaging system.

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques.…

  • Stationary X-Ray System
  • Radiation Control for Health and Safety Act
GE Medical Systems, LL…WIFeb 12, 2025
Class IIOngoingZ-1045-2025

GE Medical Systems, LLC recalls Discovery XR656 HD. X-Ray imaging system.

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques.…

  • Stationary X-Ray System
  • Radiation Control for Health and Safety Act
GE Medical Systems, LL…WIFeb 12, 2025
Class IIOngoingZ-1044-2025

GE Medical Systems, LLC recalls Discovery XR656HD. X-Ray imaging system.

The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques.…

  • Stationary X-Ray System
  • Radiation Control for Health and Safety Act
GE Medical Systems, LL…WIFeb 12, 2025

Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“System, X-Ray, Stationary”). Informational only — verify against the FDA before acting.