Official recall record
Spectral CT; Product Code (REF): 728333;
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-01-07
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00884838101111
- Brand on record
- Philips North America Llc
What the authority reported
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
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.
Record last checked against the registry on 2026-05-31.
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. - 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. - 2024-11-16 · US FDA — Medical Devices
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Other recalls from this brand
All 58 official recall notices naming Philips North America on this site →