Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1356-2016·Announced 2016-04-20

Philips Ingenuity CT Systems Recalled for Software Error in Data Transmission

Philips Medical Systems is recalling 82 Ingenuity CT systems due to a software error that may prevent the automatic transmission of image data to remote devices.

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 may cause temporary or medically reversible health consequences. The specific hazard is a software error affecting data transmission, which is a functional defect rather than a direct physical injury risk, fitting the Moderate category for non-critical software issues.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 82 units of the Ingenuity CT Computed Tomography X-ray Systems. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

The recall was initiated after the firm was notified of a software error. This error may cause the system to fail to automatically send all image and data series to remote devices. The affected units were distributed worldwide, including to the United States and numerous international locations.

Healthcare facilities and users of these systems should contact Philips Medical Systems for further instructions regarding the software issue. The recall number for this action is Z-1356-2016.

The recalled product

Product: Ingenuity CT 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: software-error
data-transmission-failure
Affected units: 82

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)

Model No. 728326
S/N: 30003
30005
30006
30007
30008
30009
30010
30011
30012
30013
30014
30015
30017
30018
30019
30020
30021
30022
30025

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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