FDAFDA · Food and drugs·Recall number Z-2711-2014
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
Published October 8, 2014 · Recall initiated: September 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution - US including the states of : AZ, CA, CT, FL, GA,MA, MS,OH, PA, TX, and WY., and the countries of : Australia, Denmark, Finland, France, Germany, India, Ireland, Japan, Malaysia, Netherlands, New Zealand, Norway, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland and United Kingdom.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.