Z-1688-2012

The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional...

Name: Z-1688-2012 The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-05-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-07 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray... on 2012-05-07. The reason FDA records is "On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit...". 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-1688-2012
Status: Terminated
Initiated: 2012-05-07
Posted: 2012-05-30
Terminated: 2013-02-26
Recalling firm: Philips North America LLC
Product: The Brilliance iCT and iCT SP are Computed Tomography 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: On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Philips Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated May 8, 2012 to all affected customers. The letter identifies the product and problem. No action is required by the customers. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Philips Healthcare will inspect the cooling units on all iCT and iCT SP systems for this issue and if the welds on a cooling unit do not pass the inspection, Philips will replace the cooling unit free of charge.
Quantity in commerce: 372
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, VT, WA and WV and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hungary, Iceland, India, Indonesia, Iraq, ISRAEL, Italy, Japan, Jordan, Korea, Lebanon, Mexico, Netherlands, New Zealand , Norway, Philippines, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates and Uzbekistan.
Product codes and lots: Brilliance iCT: Model# 728306 Brilliance iCT SP: Model# 728311

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)