Z-0389-2018Class II

Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of...

Name: Z-0389-2018 Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2017-11-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-11-10 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles... on 2017-11-10. FDA classified it as Class II and gives the reason as "Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0389-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-10
Posted: 2018-01-19
Terminated: 2020-11-05
Recalling firm: Philips North America LLC
Product: Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
FDA root cause: Under Investigation by firm
Action: An Urgent - Field Safety Notice Medical Device Correction letter, dated November 1, 2017, was sent to customers. The letter identified the affected device, described the issue, and discussed the hazard involved. Users are to cease use immediately and contact their Philips Field Service Engineer, if any unusual noises are heard within the gantry, or if the patient support tabletop is in free float. Philips Field Service Engineers will correct the system by replacing the affected fasteners. If further info or support concerning this issue is needed, customers can contact their local Philips rep or the Customer Care Solutions Center at 1-800-722-9377.
Quantity in commerce: 1
Distribution: Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
Product codes and lots: Code 728231, SN # 10655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0389-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0388-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18
Z-0389-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18
Z-0390-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18
Z-0391-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-18

Product code JAK

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

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)