Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2186-2019·Announced 2019-08-14

Philips Ingenuity CT Recalled for Potential Cardiac Image Labeling Error

Philips is recalling 92 Ingenuity CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.

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, and the hazard involves potential mislabeling of medical images without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 92 units of the Ingenuity CT, Model # 728326, computed tomography x-ray system. The recall is due to a software issue where, in certain instances, cardiac step and shoot acquisitions with phase tolerance selected may result in images being labeled as if phase tolerance had been applied when it had not.

The affected systems were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The recall covers specific system serial numbers listed in the agency documentation.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. Patients who have had cardiac imaging performed on these systems should consult their healthcare provider to determine if their images require review or re-acquisition.

The recalled product

Product: Ingenuity CT, Model # 728326, computed tomography x-ray system
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Computed Tomography (CT) Scanner
Hazard: mis-labeling
Affected units: 92

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)

System Serial Number 10474
30003
30005
30006 through 30009
30011 through 30015
30017 through 30050
30053-30054
30056
52035
52049
52051
100367 122276
300003 Through 300005
300010 through 300012
300014
300016 through 300066
300068 through 300135
300136 through 300145
300147 through 300151
300153- 300154

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · mis labeling