FDA Device recall Z-1985-2021

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

• FDA Device
• Class II
• ongoing
• Published 2021-07-07

On 2021-07-07 the FDA classified a Class II recall of Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT by Philips North America, citing significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in pot….

Read the official FDA Device notice

Product

Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

Reason

Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1985-2021%22

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