Z-2175-2018Class II

Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray...

Name: Z-2175-2018 Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-03-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-03-30 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system on 2018-03-30. FDA classified it as Class II and gives the reason as "The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2175-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-30
Posted: 2018-06-12
Terminated: 2020-04-14
Recalling firm: Philips North America LLC
Product: Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Field Safety Notices dated 3/28/18 were distributed to customers. The letters instructed customers to perform the following actions: Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the equipment Instruction for Use. As outlined in the Instructions for Use, always monitor the patient during all movements (manual or motorized) of the patient support. If you recognize an impending collision with the back shelter wall, halt the motion or activate the system E-stop. Mandatory Field Change Order (FCO) 72800686 which will add additional warning labels specific to this issue to the system. The FCO will be implemented free of charge.
Quantity in commerce: 2
Distribution: Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
Product codes and lots: System Serial Numbers: 6147, 6143

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2175-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2174-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2175-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2176-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12

Product code JAK

K012009Class IIMx8000 Idt CT SystemMarconi Medical Systems, Inc. / cleared 2001-09-13

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)