Z-2116-2016Class II

Brilliance 64, Computed Tomography X-ray system

Name: Z-2116-2016 Brilliance 64, Computed Tomography X-ray system
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2016-04-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-04-01 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to... on 2016-04-01. FDA classified it as Class II and gives the reason as "Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient...". 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-2116-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-01
Posted: 2016-07-01
Terminated: 2018-06-26
Recalling firm: Philips North America LLC
Product: Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Philips Medical Systems (Cleveland) Inc. sent an Urgent Field Safety Notice letter to affected customers , via certified letter with receipts returned for tracking purposes. The letter identified the affected product, problem and actions to be taken. Philips Healthcare is implementing software update version 3.5.5 to correct the problem. For questions contact your local Philips representative or local Philips Healthcare office.
Quantity in commerce: 94
Distribution: US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Product codes and lots: Brilliance 64: System Code #728231 Serial numbers: 9847, 9936, 9937, 9963, 10067, 10146, 10155, 10181, 10184, 10189, 10191, 10216, 10240, 10292, 10768, 10769, 10770, 10771, 10772, 10773, 10774, 10776, 10777, 10778, 10779, 10780, 10781, 10782, 10783, 10784, 10785, 10786, 10787, 10788, 10789, 10790, 10791, 10794, 10804, 10807, 29026, 29048, 29065, 29081, 29118, 29151, 91003, 95116, 95142, 95523, 95571, 95660, 95838, 95839, 95840, 95841, 95842, 95843, 95845, 95846, 95847, 95848, 95849, 95850, 95851, 95852, 95853, 95854, 95855, 95856, 95857, 95858, 95863, 95866, 95870, 95871, 95872, 95873, 95877, 95882, 95884, 95885, 95886, 95888, 95889, 95890, 95891, 95892, 95893, 95895, 95896, 95897, 95939, 6000861, 9208A, 9081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2116-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2116-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2117-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2118-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30

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