Philips Ingenuity Core CT Systems Recalled for Software Defect
Philips Medical Systems is recalling 29 Ingenuity Core CT systems due to a software defect causing intermittently slow response of the Host.
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 source text does not report any hospitalizations, injuries, or illnesses. The defect is a software performance issue (slow response) rather than a direct physical hazard, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 29 units of the Ingenuity Core Computed Tomography X-ray systems. The recall is due to a software defect that causes an intermittently slow response of the Host.
The affected systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The recall number is Z-2371-2016.
The product was distributed to 47 US states and the District of Columbia, as well as numerous countries including Canada, Mexico, and various nations in Europe, Asia, and Africa. Specific serial numbers are listed in the agency's structured data. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Ingenuity Core 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
- 29
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 #: 728321
- Serial #s: 310004
- 310005
- 310012
- 310016
- 310020
- 310021
- 310027
- 310028
- 310033
- 310034
- 310041
- 310044
- 310045
- 310057
- 310061
- 310065
- 310072
- 310074
- 310076
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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