Z-1820-2011

Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System intended to...

Name: Z-1820-2011 Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System intended to...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2010-12-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2010-12-20 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer... on 2010-12-20. The reason FDA records is "During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol". 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-1820-2011
Status: Terminated
Initiated: 2010-12-20
Posted: 2011-03-24
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System 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 the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.
Root cause tag: software
FDA root cause: Other
Action: Philips sent an URGENT - Medical Device Correction letter dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers may consider reviewing any infant images that may have been affected during the Field Test to confirm reading accuracy. For further information or support concerning this issue, customers could contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts)
Quantity in commerce: 3
Distribution: Worldwide Distribution - USA including CO, IN, and TN and the countries of Norway, Israel, and Germany
Product codes and lots: Model #728231, S/N 9089, 9551, 9548.

Product code JAK

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

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)