Philips Ingenuity Core 128 CT Systems Recalled for Software Defect
Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.
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 source text describes a software defect causing slow response without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling five units of the Ingenuity Core 128 Computed Tomography X-ray systems. The recall is due to a software defect that causes intermittently slow response of the Host.
The affected units are identified by Model # 728323 and Serial #s 310067, 320002, 320004, 320053, and 320056. These systems were distributed to numerous states in the United States and various countries internationally.
Healthcare facilities should contact the recalling firm for instructions on how to resolve the software defect.
The recalled product
- Product
- Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 5
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 (6)
- Model #: 728323
- Serial #s: 310067
- 320002
- 320004
- 320053
- 320056.
Distribution
Part of a larger recall action
This product is one of 7 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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