Z-1492-2017Class II

Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional...

Name: Z-1492-2017 Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-02-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-02-23 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of... on 2017-02-23. FDA classified it as Class II and gives the reason as "When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly...". 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-1492-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-23
Posted: 2017-03-20
Terminated: 2019-02-26
Recalling firm: Philips North America LLC
Product: Brilliance BigBore Oncology CT - 728243 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 analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Root cause tag: software
FDA root cause: Software design
Action: Philips sent an Urgent Field Safety Notice dated February 24, 2017, to all affected consignee's via certified mail with returned receipts for tracking purposes. Philips Key Market representatives will distribute the notices internationally. A Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. Implementation of the software update will be monitored. Consignees requiring further information or support concerning this issue were instructed to contact their local Philips representative. For North America and Canada, contact the Customer Care Solutions Center at 1-800-722-9377.
Quantity in commerce: 11
Distribution: Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
Product codes and lots: System Serial Number - 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1492-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1492-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1493-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)