Philips CT Systems Recalled for Software and Hardware Defects
Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The defects involve diagnostic accuracy and dose control, which are significant safety concerns for medical devices, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 139 units of the Computed Tomography X-ray Systems Ingenuity Core 128. These devices are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall is due to five identified issues: Fast Get Ready is incorrectly enabled during service procedures; contrast annotation is missing for some images when manual contrast was administered; a dot artifact is intermittently present after startup; the measured heart rate value incorrectly remains constant for some heart rate change conditions; and DoseRight is incorrectly enabled when the Exam Card specified disabling it. Additionally, there is a tube heat prediction issue.
Healthcare facilities and consumers with these specific model and serial numbers should contact Philips Medical Systems for instructions on how to resolve these defects. The affected serial numbers are listed in the official recall documentation.
The recalled product
- Product
- Computed Tomography X-ray Systems Ingenuity Core 128. 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
- Affected units
- 139
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 #728323
- Serial #s: 32010
- 32013
- 32015
- 32016
- 32018
- 32021
- 32024
- 32026
- 32032
- 32033
- 32034
- 32036
- 32037
- 32041
- 32042
- 32043
- 32044
- 32046
- 32047
Distribution
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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