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.
What this means for you
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
- 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
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 →- HighRadiation planning software recalled over image errors in three patient orientations
FDA (Devices) · 2025-09-24
- HighPinnacle 3 radiation planning software may miscalculate stopping power ratio
FDA (Devices) · 2025-08-13
- HighPinnacle3 Radiation Therapy Planning System dose-calculation software error
FDA (Devices) · 2022-09-21
- SeverePhilips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
- ModeratePhilips Forte Gamma Camera System Recalled for Detector Fall Hazard
FDA (Devices) · 2019-11-13
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02