Agency classClass IIOur severity:Severe FDA (Devices)·Z-2174-2018·Announced 2018-06-20

Philips Brilliance 64 CT System Recalled for Patient Support Head Holder Hazard

Philips is recalling three Brilliance 64 CT systems because the patient support head holder could contact the back ISO shelter wall, posing a risk of serious injury.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 under a Severe (4) classification.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling three units of the Brilliance 64 with DEPMED HARDENING KIT 12NC (Model Number 728231) Computed Tomography X-ray system. 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 defect may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios. The affected units have system serial numbers 10605, 10708, and 9208.

The recalled products 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 should contact Philips Medical Systems for further instructions on how to address this issue.

The recalled product

Product: Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: impact-injury
mechanical-defect
Affected units: 3

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 (3)

System Serial Numbers: 10605
10708
9208

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 →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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