Z-0787-04

Philips Brilliance CT Scanner System, 6, 10 & 16 slice images

Name: Z-0787-04 Philips Brilliance CT Scanner System, 6, 10 & 16 slice images
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2004-03-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-03-08 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Philips Brilliance CT Scanner System, 6, 10 & 16 slice images on 2004-03-08. The reason FDA records is "The CT couch may move downward to its lower limit without command". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0787-04
Status: Terminated
Initiated: 2004-03-08
Posted: 2004-07-20
Terminated: 2008-10-29
Recalling firm: Philips North America LLC
Product: Philips Brilliance CT Scanner System, 6, 10 & 16 slice images.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The CT couch may move downward to its lower limit without command.
FDA root cause: Other
Action: The firm contacted their Field Service Personnel by letter on 3/8/2004. The letter instructs the field personnel to immediately install the corrective firmware kits (from Siemens) on all affected units in the field.
Quantity in commerce: 97 units
Distribution: The systems were installed at medical facilities located nationwide and worldwide.
Product codes and lots: Serial Numbers: 2555 to 2568; 3335 to 3392; 9701 to 9725.

Product code JAK

K012009Class IIMx8000 Idt CT SystemMarconi Medical Systems, Inc. / cleared 2001-09-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)