The Recall Desk
SevereFDA (Devices)·Z-2175-2018·Announced 2018-06-20

Philips Brilliance 16 CT System Recalled for Head Holder Contact Hazard

Philips is recalling two Brilliance 16 CT systems because the patient support head holder may contact the back ISO shelter wall, posing a risk of serious injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the hazard may result in a 'serious injury that would require medical intervention to preclude permanent impairment,' which aligns with the rubric criterion for 'significant injury' reports under a Severe (4) classification.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling two units of the Brilliance 16 Computed Tomography X-ray system, Model Number 728240, equipped with the DEPMED HARDENING KIT 12NC. The affected systems have serial numbers 6147 and 6143.

The recall is due to a safety hazard where the patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This contact may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.

The affected units were distributed worldwide, including in the US states of California, Maryland, Nevada, Ohio, Texas, and Wisconsin, as well as in Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon. Users of these systems should contact the manufacturer for instructions on how to address the defect.

The recalled product

Product
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
2

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 (2)

  • System Serial Numbers: 6147
  • 6143

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 3 recalled by Philips Medical Systems (Cleveland) Inc 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 3 products in this recall →

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