Official recall record

Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.

What the authority reported

Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

• 2025-05-29 · US FDA — Medical Devices
  Spectral CT. Computed tomography X-ray system.
• 2026-01-07 · US FDA — Medical Devices
  Spectral CT; Product Code (REF): 728333;
• 2021-06-08 · US FDA — Medical Devices
  728333 Spectral CT 7500 -Computed Tomography X-ray system
• 2021-05-01 · US FDA — Medical Devices
  Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
• 2023-12-13 · US FDA — Medical Devices
  Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.