Agency classClass IIOur severity:High FDA (Devices)·Z-1981-2021·Announced 2021-07-07

Monitor bracket assembly recalled for detachment hazard on CT imaging systems

Philips is recalling 1,301 monitor bracket assemblies for CT/PET-CT imaging systems due to shaft wear that could cause detachment from the suspension arm, potentially resulting in the monitor falling and 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 is an FDA Class II medical device recall involving a structural failure risk (shaft wear) that could result in serious injury. No illnesses, hospitalizations, or deaths have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

Philips North America LLC is recalling Monitor Bracket Assemblies used with Continuous CT Fluoroscopy DVI Ceiling Mount and CCT Arm DVI imaging systems. These assemblies are components of Brilliance 16, Brilliance 10, Brilliance 6, and Extended Brilliance Workspace CT and PET/CT systems. Approximately 1,301 monitor bracket assemblies have been distributed worldwide.

Significant wear of the Monitor Bracket Assembly shaft may occur unrecognized. If undetected, this wear could cause the bracket assembly to detach from the suspension arm. Should detachment occur, the monitor may fall while remaining attached to the cables, creating a potential hazard of serious injury to patients, operators, bystanders, or service personnel.

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. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251…
Manufacturer: Philips North America Llc
Category: Medical Device — Medical Imaging / CT Scanner Components
Hazard: shaft-wear
fall-hazard
serious-injury-risk
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