Z-1695-2015Class II

Brilliance iCT Computed Tomography X-ray system

Name: Z-1695-2015 Brilliance iCT Computed Tomography X-ray system
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-04-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-04-13 / Terminated / root cause: supplier

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT Computed Tomography X-ray system on 2015-04-13. FDA classified it as Class II and gives the reason as "A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1695-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Posted: 2015-05-29
Terminated: 2015-10-01
Recalling firm: Philips North America LLC
Product: Brilliance iCT Computed Tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of x-ray tube mounting fasteners.
Root cause tag: supplier
FDA root cause: Other
Action: Philips sent an Urgent - Field Safety Notice dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Healthcare is recommending to stop the use of your system until the X-ray tube mounting fasteners are replaced. In addition, a Philips Field Service Engineer (FSE) will service your system via a Mandatory Field Change Order (FCO 72800638). A Philips FSE will contact you to schedule this appointment. If you need any further information or support concerning this issue, please contact your local Philips representative or your local Philips Healthcare office. This notice has been submitted to the appropriate Regulatory Agency. Philips apologizes for any inconveniences this problem has caused your organization. For further questions please call (440) 483-7600.
Quantity in commerce: 2
Distribution: Internationally to the countries of China and Norway.
Product codes and lots: Model# 728306; Serial #'s: 85019 & 85023.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1695-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1695-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-05-29

Product code JAK

K060937Class IIBrilliance VolumePhilips Medical Systems (Cleveland), Inc. / cleared 2006-06-05

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)