Z-3281-2011

Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed...

Name: Z-3281-2011 Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-06-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-06-02 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce... on 2011-06-02. The reason FDA records is "Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3281-2011
Status: Terminated
Initiated: 2011-06-02
Posted: 2011-09-27
Terminated: 2013-03-15
Recalling firm: Philips North America LLC
Product: Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. 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 difference angles and planes. This device 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: Component defect. Philips Medical decided to conduct a recall field /correction (rework) of the mounting key locking threaded insert of the Detector Module system (DMS) bolt on one (1) Brilliance 64 CT X-ray unit. The firm initiated this action following Philip's receipt of the customer's complaint reporting that the retaining inserts were pulling out of the rotor during the removal of the UDMS
FDA root cause: Other
Action: Philips sent a Field Change Order (FCO) 72800519 on June 13, 2011 to the affected customer. A Field Service Engineer visited the customer site and installed a hardware upgrade to the affected Brilliance 64 device system (Serial Number: 9592). The correction action was completed on August 9, 2011. For questions regarding this recall call 1-440-483-7000.
Quantity in commerce: 1 unit
Distribution: Nationwide Distribution including PA
Product codes and lots: Model #78231, 510(k) #K03326, Serial Number: 9592.

Product code JAK

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

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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)