Spectral CT on RailsRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

6 FDA recall records name this device's identifier, 6 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 7, 2026Class IIOpen, Classified

   Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out.

   Z-1825-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jan 7, 2026Class IIOpen, Classified

   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.

   Z-1318-2026 · Root cause: Process change control · Recall details · FDA record ↗

3. Feb 28, 2025Class IIOpen, Classified

   Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.

   Z-1324-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Dec 13, 2023Class IIOpen, Classified

   A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

   Z-1054-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Oct 9, 2023Class IIOpen, Classified

   This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).

   Z-0319-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Oct 9, 2023Class IIOpen, Classified

   When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would result in the system needing to be restarted.

   Z-0306-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗