Philips Ingenuity CT Recalled for Potential Cardiac Image Labeling Error
Philips is recalling 92 Ingenuity 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 without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 92 units of the Ingenuity CT, Model # 728326, computed tomography x-ray system. The recall is due to a software issue where, in certain instances, cardiac step and shoot acquisitions with phase tolerance selected may result in images being labeled as if phase tolerance had been applied when it had not.
The affected systems were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The recall covers specific system serial numbers listed in the agency documentation.
Healthcare facilities should contact Philips Medical Systems for instructions on how to resolve the issue. Patients who have had cardiac imaging performed on these systems should consult their healthcare provider to determine if their images require review or re-acquisition.
The recalled product
- Product
- Ingenuity CT, Model # 728326, computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 92
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 10474
- 30003
- 30005
- 30006 through 30009
- 30011 through 30015
- 30017 through 30050
- 30053-30054
- 30056
- 52035
- 52049
- 52051
- 100367 122276
- 300003 Through 300005
- 300010 through 300012
- 300014
- 300016 through 300066
- 300068 through 300135
- 300136 through 300145
- 300147 through 300151
- 300153- 300154
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.
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