The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2187-2019·Announced 2019-08-14

Philips CT System Recall for Incorrect Cardiac Image Labeling

Philips is recalling 116 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, but the hazard involves incorrect image labeling rather than a direct physical injury or high-risk pathogen. No illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 116 Ingenuity Core128 Model # 728323 computed tomography x-ray systems. The recall is due to a software issue where, during certain cardiac step and shoot acquisitions with phase tolerance selected, images may be labeled as if phase tolerance had been applied when it had not actually been applied.

The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, Mexico, and numerous other countries. The specific system serial numbers affected are listed in the source data.

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

The recalled product

Product
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT)
Hazard
Affected units
116

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 6123
  • 30016
  • 30023
  • 300068
  • 30153
  • 32000 through 320513
  • 52023
  • 52028 336001 through 336038
  • 336040 through 336051
  • 336053
  • 336055 through 336061
  • 336063 through 336379
  • 336382 through 336454
  • 336701 through 336811
  • 345218
  • 760014
  • 21003-05
  • 320309
  • 32053
  • 32060

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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