Z-0304-2019Class II

Brilliance 64 (Model No. 728231), Software version 4.1.6

Name: Z-0304-2019 Brilliance 64 (Model No. 728231), Software version 4.1.6
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-06-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-06-07 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the... on 2017-06-07. FDA classified it as Class II and gives the reason as "It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of...". 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-0304-2019
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Posted: 2018-10-31
Terminated: 2019-07-03
Recalling firm: Philips North America LLC
Product: Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm sent Customer Information letters dated June 7, 2017, to affected customers. The letter notified customers of the product issue. Customers were instructed to determine whether they had a potentially affected system by checking the software version of their device. Customers were reminded that the "Impressions" section of the report is not intended for diagnostic use. Users should instead focus on the total calcium score shown in the "Findings" section, the coronary artery score(s) and/or the "Age and Gender" graph as identified in the Instructions for Use (IFU). The firm sent a follow-up dated July 3, 2018, to inform customers that software updates had been released which resolved the issue. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America and Canada, contact the Customer Care Solutions Center (1 -800-722-9377 and follow the prompts).
Quantity in commerce: 1890
Distribution: US Nationwide Distribution
Product codes and lots: Software Version 4.1.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0304-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0303-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0304-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0305-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0306-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0307-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0308-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0309-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0310-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31
Z-0311-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31

Product code JAK

K171850Class IIPhilips CT Big BorePhilips Medical Systems (Cleveland), Inc. / cleared 2017-11-09

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)