Agency classClass IIOur severity:High FDA (Devices)·Z-0408-2016·Announced 2015-12-23

Philips Ingenuity CT Scanner Software Error Recalled by FDA

The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.

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, and the hazard involves a risk of harm (incorrect scan length) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 105 units of the Philips Healthcare Ingenuity CT Computed Tomography X-ray system. The recall was initiated by Philips Electronics North America Corporation. The affected devices were distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Canada, China, France, Germany, Japan, and the United Kingdom.

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. This discrepancy may result in the scan not covering the intended area or covering an unintended area.

Healthcare facilities should contact Philips Electronics North America Corporation for instructions on how to resolve the issue. The source text does not specify a corrective action or a deadline for resolution.

The recalled product

Product: Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Imaging Equipment
Hazard: software-error
incorrect-scan-length
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)

728326

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 error