Philips Medical Systems (Cleveland) Inc The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Ingenuity CT: 728326 300005, 300010, 300012, 300016, 300017, 300019, 300020, 300021, 300028, 300029, 300031, 300032, 300033, 300035, 300037, 300039, 300043, 300047, 300050, 300051, 300052, 300054, 300055, 300057, 300060, 300061, 300062, 300063, 300072, 300074, 300082, 300086, 300087, 300089, 300094, 300095, 300100, 300101, 300102, 300106, 300108, 300110, 300112, 300113, 300129, 300135, 300136, 300140, 300143 Ingenuity Core: 728321 310001, 310002, 310009, 310055, 310059, 310064, 310069, 310070, 310087, 333015 Ingenuity Core128: 728323 300137, 320003, 320005, 320006, 320018, 320024, 320029, 320030, 320033, 320037, 320078, 320092, 320099, 320103, 320114, 336011, 336012, 336013, 336016, 336018
Products Sold
Ingenuity CT: 728326 300005,300010,300012,300016,300017,300019,300020,300021,300028,300029, 300031,300032,300033,300035,300037,300039,300043,300047,300050,300051, 300052,300054,300055,300057,300060,300061,300062,300063,300072,300074, 300082,300086,300087,300089,300094,300095,300100,300101,300102,300106, 300108,300110,300112,300113,300129,300135,300136,300140,300143 Ingenuity Core: 728321 310001,310002,310009,310055,310059,310064,310069,310070,310087,333015 Ingenuity Core128: 728323 300137,320003,320005,320006,320018,320024,320029,320030,320033,320037, 320078,320092,320099,320103,320114,336011,336012,336013,336016,336018
Philips Medical Systems (Cleveland) Inc is recalling The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray syste due to Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, FL, GA, MA, MS, OH, PA, TX, WY
Page updated: Jan 10, 2026