Agency classClass IIOur severity:High FDA (Devices)·Z-0406-2016·Announced 2015-12-23

Philips Ingenuity Core CT Scanner Software Recall

Philips is recalling 105 Ingenuity Core CT scanners because software may set the scan length differently than planned during specific protocols.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a software error that alters scan parameters, which is a risk-of-harm product defect where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported or is theoretical.

Plain-English summary

Philips Electronics North America Corporation is recalling 105 units of the Philips Healthcare Ingenuity Core Computed Tomography X-ray system. The recall is due to a software defect where, during scans with specific protocol steps, the system unexpectedly sets the Axial (2 axis) scan length to a different length than the user set in the plan.

The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as Argentina, Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom. The specific code information for the affected units is 728321.

Healthcare facilities should contact Philips Electronics North America Corporation for instructions on how to resolve the software issue. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product: Philips Healthcare Ingenuity Core Computed Tomography X-ray system
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: software-defect
incorrect-scan-parameters
Affected units: 105

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 (1)

728321

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Philips Electronics North America Corporation 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 4 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · software defect