Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2203-2015·Announced 2015-07-29

Philips Recalls Head Holders for Ingenuity Core CT Systems

Philips is recalling 79 head holders shipped with Ingenuity Core CT systems because they were not qualified for use on this specific model.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a qualification issue rather than a reported injury or structural defect, fitting the Moderate criteria for low-risk or precautionary recalls.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 79 head holders that were shipped with Ingenuity Core Computed Tomography (CT) X-ray systems. The recall is due to the fact that these head holders were released for use with other CT systems but had not yet been qualified for use on the Ingenuity Core system.

The affected head holders have Model Number 4535 671 11331. They were shipped to facilities in 33 U.S. states and 36 countries worldwide. The recall covers specific serial numbers associated with the Ingenuity Core systems, including a range from 7725 to 310080, as well as specific alphanumeric serials.

Healthcare facilities should stop using the affected head holders with the Ingenuity Core CT systems. Philips is the recalling firm and is responsible for managing the recall process.

The recalled product

Product: Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: unqualified-device
Affected units: 79

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)

Head Holder M/N 4535 671 11331. Ingenuity Core - M/N 728321
Serial #s: 7725
10614
10663
50171
95735
300072
310001
310006
310008
310009
310010
310012
310013
310014
310015
310017
310018
310020
310021

Distribution

Distributed in 32 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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