The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2192-2019·Announced 2019-08-14

Philips IQon Spectral CT Recall for Cardiac Image Labeling Error

Philips is recalling 25 IQon Spectral 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 a labeling error in medical imaging software without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 25 IQon Spectral CT Model # 728332 computed tomography x-ray systems. The recall involves systems with serial numbers 860004 through 860043, 860046 through 860127, and 890002. These units were distributed worldwide, including the United States, Canada, and Mexico.

The recall is due to a software issue where, in certain instances during a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when it had not actually been applied. This mislabeling could affect the interpretation of the cardiac images.

Healthcare facilities and users of these systems should contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA.

The recalled product

Product
IQon Spectral CT Model # 728332, computed tomography x-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography
Hazard
Affected units
25

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 (3)

  • System Serial Number 860004 through 860043
  • 860046 through 860127
  • 890002

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 →

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