Z-1716-2016Class II

Philips Healthcare Ingenuity Core Computed Tomography X-Ray System

Name: Z-1716-2016 Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Creator: Philips Healthcare
Published: 2015-09-06
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-09-06 / Terminated / root cause: software

FDA source

Philips Healthcare began a recall of Philips Healthcare Ingenuity Core Computed Tomography X-Ray System on 2015-09-06. FDA classified it as Class II and gives the reason as "Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of...". 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-1716-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-06
Posted: 2016-06-06
Terminated: 2021-03-04
Recalling firm: Philips North America LLC
Product: Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
Root cause tag: software
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips plans to initiate a field corrective action that will install a new software release to address the issue. Philips will modify the systems in the field to correct the defect at no cost to the customer. 1. You will contact customers and initiate a software update to correct the defect. 2. You will install the software and perform testing to ensure the software update was effective. 3. The customer notification letter which includes a statement that you will without charge, remedy the defect or bring the product into compliance. For further questions, please call (1-800) 722-9377, Option 5
Quantity in commerce: US-423
Distribution: US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
Product codes and lots: Software v. 4.13, 4.14 and 4.15.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1716-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1713-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1714-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1715-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1716-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1717-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1718-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06
Z-1719-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-06

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)