Official recall record

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

US FDA — Medical Devices · 2023-10-09 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-10-09
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838103627
Brand on record: Philips North America

What the authority reported

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).

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.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-02-28 · US FDA — Medical Devices
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
2026-03-07 · US FDA — Medical Devices
Philips Spectral CT on Rails. Model Number: 728334.
2023-10-09 · US FDA — Medical Devices
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Other recalls from this brand

2026-08-28 · US FDA — Medical Devices
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341 (1.5T), 3. 781396 (1.5T),
2026-08-28 · US FDA — Medical Devices
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3.
2026-08-28 · US FDA — Medical Devices
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software Versions: R11, R12 and R13

All 75 official recall notices naming Philips North America on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.