Z-3209-2011

Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005...

Name: Z-3209-2011 Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-06-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-06-15 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are... on 2011-06-15. The reason FDA records is "Software errors. Philips Medical's Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced...". 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-3209-2011
Status: Terminated
Initiated: 2011-06-15
Posted: 2011-09-14
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software errors. Philips Medical's Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors.
Root cause tag: software
FDA root cause: Other
Action: Philips Medical ( Cleveland) Inc. indicated in the Correction and Removal Report dated June 21, 2011, that a Philips Field Service Engineer will be contacting each site in order to schedule a time to implement the Field Change Order. After which time, the Field Service Engineer will visit each customer site to install the software upgrade and the firm will be tracking the progress of this corrective action. For further questions please call (440) 483-7000.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution -- USA (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.
Product codes and lots: Model #728311, Serial Numbers: 200005, 200013, and 200047.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)