Agency classClass IIOur severity:High FDA (Devices)·Z-1990-2021·Announced 2021-07-07

Monitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems

Philips CT fluoroscopy monitor brackets may detach from suspension arms due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries, but significant structural risk: undetected shaft wear may cause equipment detachment and monitor fall, potentially causing serious injury to patients, operators, bystanders, and service personnel. This fits the Score 3 (High) criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy systems with ceiling-mounted monitors on Brilliance iCT models 728306 and 728311. These bracket assemblies secure the fluoroscopy monitor to the suspension arm.

The recall addresses a potential failure mechanism: significant wear of the Monitor Bracket Assembly shaft can occur without being detected by operators or maintenance personnel. This unrecognized wear may cause the bracket assembly to detach from the suspension arm, allowing the monitor to fall while remaining attached to its cables. This creates a serious hazard of injury to patients, operators, bystanders, or service personnel in the examination room.

Facilities with affected equipment should contact Philips for inspection and remediation guidance. The recall affects units distributed worldwide, including the United States, Canada, Mexico, and multiple other countries. Affected serial numbers are provided in the recall notice.

The recalled product

Product: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: shaft-wear
equipment-detachment
fall-hazard
Affected units: 1,301

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Philips North America Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Same manufacturer · Philips North America Llc

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Same hazard · shaft wear