Z-2711-2014Class II

The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems...

Name: Z-2711-2014 The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-09-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-09-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body... on 2014-09-11. FDA classified it as Class II and gives the reason as "Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2711-2014
Classification: Class II
Status: Terminated
Initiated: 2014-09-11
Posted: 2014-09-29
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
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
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user.
Root cause tag: software
FDA root cause: Software design
Action: Philips sent an Urgent - Field Safety Notice Medical Device Correction letter dated September 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. Additionally, a Field Service Engineer will contact each site to schedule a time to install the software update. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America, contact the Customer Care Solutions Center (1.800.722-9377 and follow the prompts).
Quantity in commerce: 79
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2711-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2711-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)