Z-1774-2021Class II

BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and...

Name: Z-1774-2021 BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and...
Creator: Philips North America Llc
Published: 2021-04-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-04-13 / Terminated

FDA source

Philips North America Llc began a recall of BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 on 2021-04-13. FDA classified it as Class II and gives the reason as "Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1774-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-13
Posted: 2021-06-02
Terminated: 2022-09-23
Recalling firm: Philips North America LLC
Product: BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
FDA root cause: Under Investigation by firm
Action: Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service.
Quantity in commerce: 2 units (1 US and 1 OUS)
Distribution: Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Product codes and lots: Serial Numbers: 100100, 100434

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1774-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1774-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02

Product code JAK

K060937Class IIBrilliance VolumePhilips Medical Systems (Cleveland), Inc. / cleared 2006-06-05

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)