Agency classClass IIOur severity:High FDA (Devices)·Z-1983-2021·Announced 2021-07-07

CT Monitor Bracket Assembly Recalled Due to Shaft Wear and Detachment Risk

Philips North America is recalling CT system monitor bracket assemblies due to shaft wear that could cause the bracket to detach from the suspension arm, potentially allowing the monitor to fall and cause serious injury.

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: This recall concerns a risk-of-harm product where serious injury could result from a monitor falling, but no illnesses or injuries have been reported. The hazard mechanism is specific and documented but has not resulted in reported harm to date.

Plain-English summary

Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies for Continuous CT Fluoroscopy DVI ceiling-mounted imaging systems used in CT and PET/CT diagnostic facilities. The recalled components are used in Brilliance Big Bore models and function to mount and position monitors within clinical imaging settings.

The recall was initiated because significant wear of the Monitor Bracket Assembly shaft may develop without being recognized. If undetected, this wear could lead to the bracket detaching from its suspension arm. Because the monitor remains connected by electrical cables during detachment, the bracket failure could result in the monitor falling.

A falling monitor presents a serious injury risk to patients, operators, bystanders, and service personnel in healthcare environments. The 1,301 affected bracket assemblies were distributed worldwide, including throughout the United States, Canada, Mexico, and numerous other countries. Facilities with these systems should contact Philips North America LLC for instructions regarding inspection, maintenance, and replacement of affected units.

The recalled product

Product: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: bracket-wear
detachment-risk
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 · bracket wear