Z-0547-2019Class II

Brilliance 10 Slice (Air), Model 728251

Name: Z-0547-2019 Brilliance 10 Slice (Air), Model 728251
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-10-18
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-10-18 / Terminated / root cause: manufacturing process

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer... on 2018-10-18. FDA classified it as Class II and gives the reason as "There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0547-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-18
Posted: 2018-11-30
Terminated: 2021-08-03
Recalling firm: Philips North America LLC
Product: Brilliance 10 Slice (Air), Model 728251 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: There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On October 18, 2018, Philips notices to their customers via courier service. Customers were advised to take the following actions: If any unusual noise is heard, discontinue use of the system immediately and contact your Philips representative for support. Field Order Change (FCO) 72800703 will be deployed to initiate an inspection of the front gantry cover. If the inspection finds evidence of weakening at this connection point, a temporary repair solution will be put in place to secure the cover for continued system use. FCO 72800704 will then be deployed to replace the affected front cover. A Philips Field Service Engineer will contact you to schedule the inspection of your system. Customers in need of further information or support concerning this issue, please contact your local Philips representative (North America & Canada) 1-800-722-9377.
Distribution: US Nationwide Distribution
Product codes and lots: System Serial Number: 2598 3008 3098 4001 4002 4003 4005 4006 4007 4008 4009 4010 4011 4012 4014 4015 4016 4020 4021 4022 4023 4026 4027 4028 4029 4030 4031 4032 4033 4034 4035 4039 4040 4044 4045 4047 4048 4049 4050 4052 4053 4054 4056 4058 4059 4061 4062 4063 4064 4065 4066 4067 30099 40004 40005 40006 40007 40008 40009 40010 40011 40012 40014 40015 40016 40018 40019 40020 40021 40023 40025 40028 40029 40031 40032 40034 62986554 4008/6086 4039/7128 728251_859-1766

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0547-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0543-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0544-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0545-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0546-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0547-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30
Z-0548-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-11-30

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