Z-0594-2017Class III

Brilliance ICT SP Computed Tomography X-ray system, Model 728311

Name: Z-0594-2017 Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-10-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-10-13 / Terminated / root cause: labeling and UDI

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance ICT SP Computed Tomography X-ray system, Model 728311 on 2016-10-13. FDA classified it as Class III and gives the reason as "The product label does not include the correct current rating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0594-2017
Classification: Class III
Status: Terminated
Initiated: 2016-10-13
Posted: 2016-11-16
Terminated: 2018-06-29
Recalling firm: Philips North America LLC
Product: Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The product label does not include the correct current rating.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm will send a customer letter via certified mail and will have the receipts returned for tracking purposes. Also, a Field Service Engineer will implement the Field Change Order on affected systems to resolve the issue. Implementation of the Field Change Order will be monitored.
Quantity in commerce: 3
Distribution: Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY H, 1650 Cochrane Cir, Colorado Springs, CO 80913; US VETERANS ADMINISTRATION, 3710 SW US VETERANS HOSPITAL, PORTLAND, OR 97239; VA MEDICAL CENTER, 4100 W 3RD ST, DAYTON, OH 45428; VAMC - PHILADELPHIA, UNIVERSITY & WOODLAND AVE, PHILADELPHIA, PA 19104. There are five (5) Canadian accounts for this recall: FIVE HILLS HEALTH REGION, 55 DIEFENBAKER DR, MOOSE JAW, SASKATCHEWAN S6J 0C2; INSTITUT UNIV CARDIOLOGIE, 2725 CH STE FOY, SAINTE FOY, QUEBEC G1V 4G5; LAKERIDGE HEALTH, 1 HOSPITAL CRT, OSHAWA, ONTARIO L1G 2B9; LAKERIDGE HEALTH BOWMANVI, 47 LIBERTY ST S, BOWMANVILLE, ONTARIO L1C 2N4; MCGILL UNIVERSITY HEALTH, 1051 BOUL D¿CARIE, MONTR¿AL, QUEBEC H4A 0A5. There were zero (0) Mexican accounts for this recall. The recalled products were shipped to the following countries: Argentina, Australia, Belgium, China, Egypt, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Republic of Korea, Lebanon, Netherlands, New Zealand, Norway, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: 200208, 200211, 200213

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0594-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0593-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0594-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0595-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0596-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0597-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16
Z-0598-2017	Class III	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)