Philips Ingenuity Core CT System Recalled for Perfusion Software Access Issue
Philips Medical Systems is recalling 135 Ingenuity Core CT systems because a software upgrade may have restricted access to the basic axial perfusion feature for some users.
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, but the source text describes a software access limitation without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving functional limitations or precautionary measures where no harm has been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 135 units of the Ingenuity Core Computed Tomography X-ray system (Model No. 728321). The recall involves specific serial numbers distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and the Middle East.
The recall was initiated because the perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers who previously used the basic axial perfusion software (versions preceding 4.1.2) without purchasing the helical perfusion license key were unable to access the basic axial perfusion feature after upgrading to software version 4.1.2.
This issue affects facilities that upgraded their software and relied on the basic axial perfusion feature. The source text does not report any injuries, illnesses, or deaths associated with this software access issue. Affected customers should contact Philips Medical Systems for further instructions regarding software access and resolution.
The recalled product
- Product
- Ingenuity Core Computed Tomography X-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 135
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)
- Model No. 728321
- S/N: 52007
- 52008
- 52010
- 52013
- 52014
- 52015
- 52018
- 52019
- 52020
- 52021
- 52024
- 52027
- 52032
- 52033
- 52034
- 52035
- 52036
- 52037
- 52038
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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