The Recall Desk
SevereFDA (Devices)·Z-2176-2018·Announced 2018-06-20

Philips Brilliance 16 P CT Systems Recalled for Head Holder Contact Risk

Philips is recalling 20 Brilliance 16 P 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 defect 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 or risks, warranting a score of 4.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 20 Brilliance 16 P Computed Tomography X-ray systems, Model Number 728246, equipped with the DEPMED HARDENING KIT 12NC. The recall affects specific system serial numbers listed in the agency record.

The recall is due to a defect 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 United States (CA, MD, NV, OH, TX, WI) and in Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon. Users should contact the recalling firm for instructions on how to resolve the issue.

The recalled product

Product
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
20

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 (20)

  • System Serial Numbers: 5380
  • 5379
  • 5520
  • 5524
  • 5538
  • 5539
  • 5549
  • 5779
  • 5792
  • 5778
  • 5808
  • 5887
  • 5888
  • 5973
  • 6020
  • 6026
  • 6110
  • 6097
  • 6352
  • 6424

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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