The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1980-2021·Announced 2021-07-07

Philips Continuous CT Fluoroscopy Monitor Bracket Assembly Fall Risk

Philips is recalling 1,301 Monitor Bracket Assemblies due to shaft wear that could cause the assembly to detach from the ceiling suspension arm. This could result in the monitor falling and causing serious injury to patients, operators, bystanders, 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 an FDA Class II device with a documented failure mechanism—shaft wear leading to structural detachment. While the potential for serious injury is significant, no actual injuries or hospitalizations are reported in the source, fitting the 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 with Continuous CT Fluoroscopy systems (Model 728131). These components are ceiling-mounted to support monitors on CT and MX16 imaging equipment.

The Monitor Bracket Assembly shaft can experience significant wear that may go unnoticed. When this wear is advanced, the assembly can detach from the ceiling suspension arm to which it is mounted.

If the assembly detaches, the monitor can fall while still connected to its cables. This falling equipment poses a risk of serious injury to patients, equipment operators, bystanders, or service personnel.

Affected healthcare facilities and service providers should contact Philips North America LLC regarding their installed systems. The recall affects equipment distributed worldwide, including throughout the United States and to over 40 additional countries.

The recalled product

Product
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 Models: 728131
Manufacturer
Philips North America Llc
Category
Medical Device — CT Imaging Equipment
Hazard
Affected units
1,301

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model/ Serial Number/UDI: N/A

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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