The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2194-2019·Announced 2019-08-14

Philips Recalls Vereos PET/CT Systems Due to Image Labeling Error

Philips is recalling 26 Vereos PET/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. The hazard involves a software labeling error that could lead to misinterpretation of images, but no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 26 units of the Vereos PET/CT Model # 882446 computed tomography x-ray system. The recall affects systems with serial numbers 900004 through 900076.

The recall was initiated because, in certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not actually been applied. This labeling error could lead to misinterpretation of the cardiac imaging data.

The affected devices were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. Healthcare facilities and users of these systems should contact Philips Medical Systems for further instructions on how to address the labeling issue.

The recalled product

Product
Vereos PET/CT Model # 882446, computed tomography x-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
26

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)

  • System Serial Number 900004 through 900076

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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