Z-0016-2018Class II

Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are...

Name: Z-0016-2018 Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are...
Creator: Philips Electronics North America Corporation
Published: 2017-01-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-01-18 / Terminated / root cause: manufacturing process

FDA source

Philips Electronics North America Corporation began a recall of Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the... on 2017-01-18. FDA classified it as Class II and gives the reason as "During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0016-2018
Classification: Class II
Status: Terminated
Initiated: 2017-01-18
Posted: 2017-10-13
Terminated: 2020-02-26
Recalling firm: Philips North America LLC
Product: Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Philips will bring defect into compliance: 1. Will issue a customer notification letter. 2. Will provide a software update, at no cost to the customer. 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. You will implement this CAP by April 30, 2018. If you need any further information or support concerning this issue, please contact your local Philips representative or the Customer Care Solutions Center at 1-800-722 9377. .
Quantity in commerce: US - 606
Distribution: USA (nationwide) Distribution
Product codes and lots: Software version 4.16

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0016-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0015-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-13
Z-0016-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-13
Z-0017-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-13
Z-0018-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-13
Z-0019-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-13
Z-0020-2018	Class II	Terminated	FDA Mandated	2017-10-25	2017-10-13

Product code JAK

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)