Z-0407-2016Class II

Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system

Name: Z-0407-2016 Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Creator: Philips Electronics North America Corporation
Published: 2015-04-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-04-14 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system on 2015-04-14. FDA classified it as Class II and gives the reason as "During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan". 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-0407-2016
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Posted: 2015-12-12
Terminated: 2020-09-23
Recalling firm: Philips North America LLC
Product: Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips Healthcare Planned Action: 1. Philips Healthcare will contact customers and initiate a software update to correct the defect. 2. Philips Healthcare engineers will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that Philips Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Philips Healthcare will implement this CAP by April 1, 2016. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
Quantity in commerce: 105
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.
Product codes and lots: 728323

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0407-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0405-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-12
Z-0406-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-12
Z-0407-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-12
Z-0408-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-12

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)