The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1986-2021·Announced 2021-07-07

Philips CT Monitor Bracket Assemblies Recalled for Detachment Risk

Philips has recalled 1,301 Monitor Bracket Assemblies for CT systems worldwide due to shaft wear that could cause monitors to detach and fall, potentially injuring patients, operators, or service personnel.

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 a Class II medical device recall involving a risk-of-harm product (detachable ceiling-mounted monitor) capable of causing serious injury. The source text uses conditional language ('could potentially') with no reported incidents, placing it at the upper bound of theoretical hazards per the rubric.

Plain-English summary

Philips North America LLC is recalling 1,301 Monitor Bracket Assemblies used in Continuous CT Fluoroscopy systems with DVI ceiling mounts. The affected units were distributed worldwide, including throughout the United States, Canada, Mexico, and numerous other countries.

Significant wear of the Monitor Bracket Assembly shaft can go unrecognized and cause the assembly to detach from the Suspension Arm. When this occurs, the monitor can fall while remaining attached to the cables, creating a serious injury hazard to patients, operators, bystanders, and service personnel.

Facilities using affected CT systems should inspect monitor bracket assemblies for signs of shaft wear and contact Philips for service instructions. No injuries or incidents have been reported in connection with this issue as of the recall announcement.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Manufacturer
Philips North America Llc
Category
Medical Device — Imaging Equipment / Ceiling Mount
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 →

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