FDA Device recall Z-2034-2025

Spectral CT. Computed tomography X-ray system

• FDA Device
• Class II
• ongoing
• Published 2025-07-02

On 2025-07-02 the FDA classified a Class II recall of Spectral CT. Computed tomography X-ray system by Philips North America, citing devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional….

Read the official FDA Device notice

Product

Spectral CT. Computed tomography X-ray system.

Reason

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2034-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.