Philips Ingenuity Core 128 CT Systems Recalled for Emergency Stop Defect
Philips is recalling 591 Ingenuity Core 128 CT systems because closing the emergency stop may allow the patient couch to move during loading or unloading.
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 and involves a mechanical defect that poses a risk of physical injury to patients during loading or unloading, but no injuries or deaths are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 591 units of the Ingenuity Core 128 Computed Tomography (CT) X-Ray system, model numbers 728323 and 728324. The recall was initiated by the U.S. Food and Drug Administration (FDA) and classified as Class II.
The recall is due to a defect where closing the Emergency Stop may disable the horizontal motor. This failure allows the couch top to move during patient load or unload activities, posing a risk of injury to patients or staff. The affected units were distributed worldwide, including across the United States and numerous international locations.
Healthcare facilities should contact Philips Medical Systems to arrange for the necessary corrective actions. The source text does not specify the exact corrective measure, but the recall is intended to address the mechanical hazard associated with the emergency stop function.
The recalled product
- Product
- Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems 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
- 591
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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