The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2193-2019·Announced 2019-08-14

Philips Ingenuity TF PET/CT Recalled for Cardiac Image Labeling Error

Philips is recalling 12 Ingenuity TF 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, and the hazard involves potential mislabeling of medical images which could lead to misinterpretation, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 12 Ingenuity TF PET/CT Model # 882456 computed tomography x-ray systems. 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.

The affected systems were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The recall covers systems with specific serial numbers and model years ranging from 2003-2006, 2012-2013, and 2015 through 2027.

Healthcare facilities 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 TF PET/CT Model # 882456, computed tomography x-ray system
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
Affected units
12

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 (8)

  • System Serial Number 2003-2006
  • 2012-2013
  • 2015 through 2027
  • 7550
  • 7560
  • 7579
  • 9219
  • 9221

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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