Agency classClass IIOur severity:High FDA (Devices)·Z-1988-2021·Announced 2021-07-07

Philips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems

Philips monitor bracket assemblies for CT/PET imaging systems may detach due to shaft wear, posing a risk of 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 involving a mechanical failure (shaft wear) that could cause serious injury through device detachment and falling. No illnesses or injuries have been reported, meeting the criteria for a risk-of-harm medical device without reported harm.

Plain-English summary

Philips North America is recalling approximately 1,301 Monitor Bracket Assemblies used in medical imaging systems. These components are part of Continuous CT Fluoroscopy DVI Ceiling Mount systems and CCT Arm DVI Option configurations for PET/CT imaging equipment (model 882446).

The Monitor Bracket Assembly shaft can experience significant wear that may not be immediately recognized. When this wear becomes severe enough, the bracket assembly can detach from the suspension arm, allowing the monitor to fall while remaining attached to its electrical cables.

This detachment and fall creates a potential hazard where patients, operators, bystanders, or service personnel could suffer serious injury. The affected devices have been distributed worldwide, including throughout the United States, Canada, Mexico, and numerous other countries.

The recalled product

Product: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
Manufacturer: Philips North America Llc
Category: Medical Device — Imaging Equipment Mounting
Hazard: shaft-wear
detachment
fall-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 882446 900115 (01)00884838059559(21)900115

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