Z-0546-2016Class II

Brilliance iCT SP Computed Tomography X-ray system

Name: Z-0546-2016 Brilliance iCT SP Computed Tomography X-ray system
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2015-10-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2015-10-29 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT SP Computed Tomography X-ray system on 2015-10-29. FDA classified it as Class II and gives the reason as "Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the...". 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-0546-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Posted: 2015-12-24
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: Brilliance iCT SP Computed Tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
Root cause tag: software
FDA root cause: Software design
Action: On 10/30/2015 the firm sent Customer Information letters to their Consignees.
Quantity in commerce: 12 Units
Distribution: Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
Product codes and lots: Model No. 728311; S/N: 200047, 200051, 200067, 200074, 200098, 200127, 200200, 200202, 200203, 200204, 200206 & 200209.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0544-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24
Z-0545-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24
Z-0546-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24
Z-0547-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24
Z-0548-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24
Z-0549-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

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)