Agency classClass IIOur severity:High FDA (Devices)·Z-1989-2021·Announced 2021-07-07

Philips Medical Monitor Bracket May Detach from Ceiling Mount

Philips medical imaging monitors with worn bracket assembly shafts may detach from ceiling suspensions and fall on patients, operators, or staff. No injuries have been reported.

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 medical device with potential for serious patient and staff injury from falling overhead equipment, but no reported injuries or hospitalizations. The hazard is clearly serious—a ceiling-mounted monitor falling on patients or operators could cause death—but remains theoretical/potential.

Plain-English summary

Philips North America is recalling Monitor Bracket Assemblies used in certain continuous CT fluoroscopy systems with ceiling-mounted imaging monitors. The bracket assembly shaft can experience significant wear over time, and if this wear goes unrecognized, the monitor bracket assembly may detach from the ceiling suspension arm.

When detachment occurs, the monitor can fall while remaining attached to electrical and communication cables. This creates a hazard of the monitor striking patients, operators, bystanders, or service personnel, potentially causing serious injury.

This recall affects approximately 1,301 monitor bracket assemblies that have been distributed worldwide, including across the United States, Canada, Mexico, and over 60 additional countries. Healthcare facilities using the affected equipment should inspect monitor brackets for signs of wear and contact Philips for guidance on repair or replacement.

Philips has classified this as a Class II recall. No injuries or deaths have been reported at this time.

The recalled product

Product: Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / Ceiling Mount
Hazard: structural-failure
falling-hazard
impact-injury
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 882476 9006 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 →

Same manufacturer · Philips North America Llc

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Same hazard · structural failure