Z-0400-2016Class II

Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version...

Name: Z-0400-2016 Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2006-04-25
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-04-25 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross... on 2006-04-25. FDA classified it as Class II and gives the reason as "Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on...". 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-0400-2016
Classification: Class II
Status: Terminated
Initiated: 2006-04-25
Posted: 2015-12-10
Terminated: 2015-12-15
Recalling firm: Philips North America LLC
Product: Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems sent a product safety notice to customers and corrective software for the issue was released to the field on July 25, 2006. Service Reps will contact each customer to install the new version of software. For questions regarding this recall call 440-483-7600.
Quantity in commerce: 54 units
Distribution: Worldwide distribution, including US states of CA and NV.
Product codes and lots: Model # 728243 Software Version 2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0400-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0400-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

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)