Philips CT System Recall for Incorrect Phase Tolerance Image Labeling
Philips is recalling Ingenuity Core CT systems because 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, but the hazard involves incorrect image labeling rather than a direct physical injury mechanism, and no injuries or illnesses have been reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 202 units of the Ingenuity Core Model # 728321 computed tomography x-ray system. 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 units 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. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Ingenuity Core Model # 728321, computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 202
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 10634
- 31001
- 52000- 52001
- 52003- 52004
- 52006 through 52022 52024- 52027
- 52029 through 52073
- 52075 through 52102
- 52104 through 52158
- 52160- 52161
- 95726
- 95738
- 95739
- 100827
- 122416
- 200090
- 300087
- 300095
- 300155
- 310001- 310002
- 310006- 310008
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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