The Recall Desk
HighFDA (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.

What this means for you

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

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.

Related recalls

Same category