Z-0409-2016Class II

Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to...

Name: Z-0409-2016 Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2011-03-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-03-03 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer... on 2011-03-03. FDA classified it as Class II and gives the reason as "Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0409-2016
Classification: Class II
Status: Terminated
Initiated: 2011-03-03
Posted: 2015-12-10
Terminated: 2015-12-15
Recalling firm: Philips North America LLC
Product: Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Multiple software defects which could impact the performance or reliability of the system. These impacts include, but are not limited to: error messages which prevent operation, incorrect scan region, couch movement failure, inaccurate CTDI reporting, image artifacts, lost images. There is a risk of misdiagnosis.
Root cause tag: software
FDA root cause: Software design
Action: On March 3, 2011, the firm sent Field Service Notices to their customers.
Quantity in commerce: 1,765 units
Distribution: Worldwide Distribution. US nationwide, including Puerto Rico, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Equatorial Guinea, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam & Yemen.
Product codes and lots: Serial numbers: 4001, 4020, 4021, 9030, 9033, 9040, 9041, 9048, 9049, 9062, 9074, 9083, 9093, 9105, 9106, 9107, 9108, 9112, 9123, 9126, 9127, 9131, 9135, 9137, 9139, 9140, 9142, 9148, 9151, 9159, 9160, 9162, 9163, 9166, 9171, 9173, 9175, 9177, 9180, 9196, 9197, 9201, 9202, 9205, 9206, 9208, 9214, 9215, 9216, 9217, 9218, 9235, 9501, 9502, 9503, 9504, 9505, 9506, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9516, 9517, 9518, 9519, 9520, 9521, 9522, 9523, 9524, 9525, 9526, 9527, 9528, 9529, 9530, 9531, 9532, 9533, 9535, 9536, 9537, 9538, 9539, 9540, 9541, 9542,9543, 9544, 9545, 9546, 9547, 9548, 9549, 9550, 9551, 9552, 9553, 9554, 9555, 9556, 9557, 9558, 9559, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9573, 9574, 9575, 9576, 9577, 9578, 9579, 9580, 9581, 9582, 9583, 9584, 9585, 9586, 9587, 9588, 9589, 9590, 9591, 9592, 9593, 9594, 9595, 9596, 9597, 9598, 9599, 9600, 9601, 9602, 9603, 9604, 9605, 9606, 9607, 9608, 9610, 9611, 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95696, 95697 and 410249.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0409-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0409-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-16	2015-12-10

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