Z-1464-2014Class II

Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc

Name: Z-1464-2014 Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2014-03-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-03-06 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc on 2014-03-06. FDA classified it as Class II and gives the reason as "A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete". 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-1464-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-06
Posted: 2014-04-16
Terminated: 2014-11-05
Recalling firm: Philips North America LLC
Product: Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: .The firm, Phillips, sent an " URGENT Medical Device Correction" letter dated 2013 March 06, to its costumers . The letter disc ribes the product, problem and actions to be taken. The costumers were instructed to Verify that all planned image reconstructions are completed, and Perform off-line reconstructions if expected images are missing. The firm will release A Field Change Order (FCO) to correct the issue with software version release 3.5.7.and A Philips Field Service Engineer will contact you to schedule the software installation at your site. 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 and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts).
Quantity in commerce: 116 units
Distribution: Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.
Product codes and lots: System code: 728323; Serial #: 320002, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320031, 320032, 320034, 320035, 320036, 320037, 320038, 320039, 320040, 320041, 320043, 320044, 320045, 320046, 320047, 320048, 320049, 320050, 320051, 320052, 320053, 320054, 320055, 320056, 320057, 320059, 320060, 320062, 320063, 320064, 320065, 320066, 320067, 320068, 320069, 320070, 320071, 320072, 320074, 320075, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320085, 320086, 320087, 320088, 320089, 320090, 320092, 320093, 320095, 320096, 320097, 320098, 320099, 320101, 320102, 320103, 320104, 320105,320106, 320107, 320109, 320110, 320111, 320112, 320114, 320115, 320116, 320117, 320118, 320119, 320120, 320121, 320122, 336013 & 336015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1464-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1464-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-23	2014-04-16

Product code KPS

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)