The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2191-2019·Announced 2019-08-14

Philips Brilliance 64 CT System Recalled for Image Labeling Error

Philips is recalling 582 Brilliance 64 CT systems because 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 is a labeling error that could lead to misinterpretation of images, which fits the criteria for moderate severity involving minor labeling errors or low-risk issues.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 582 Brilliance 64 Model # 728231 computed tomography x-ray systems. The recall is due to a software issue where, during 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 systems were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The recall notice does not specify a date range for the distribution or the specific serial numbers affected beyond the provided list.

Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Brilliance 64 Model # 728231, computed tomography x-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
582

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 335
  • 338
  • 1897
  • 4001
  • 4003
  • 4016
  • 4021
  • 9009
  • 9029-9030
  • 9033
  • 9035
  • 9038
  • 9040
  • 9045
  • 9047
  • 9048
  • 9052
  • 9054
  • 9056
  • 9058

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 →

Related recalls

Same manufacturer · Philips Medical Systems (Cleveland) Inc

See all →

Same hazard · mis labeling

See all →

Similar recalls