Z-2210-2013Class II

Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N...

Name: Z-2210-2013 Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-07-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-07-05 / Terminated / root cause: design

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143... on 2013-07-05. FDA classified it as Class II and gives the reason as "The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch". 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-2210-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-05
Posted: 2013-09-16
Terminated: 2015-09-15
Recalling firm: Philips North America LLC
Product: Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch.
Root cause tag: design
FDA root cause: Component design/selection
Action: Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Care Center at 1-800-722-9377, option 5 for information concerning this issue.
Quantity in commerce: M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units
Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, France, Germany, Greenland, Iceland, Indonesia, Israel, Japan, Kazakhstan, Netherlands, Nigeria, Norway, Poland, Romania, South Africa, South Korea, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom & Vietnam.
Product codes and lots: Model #, 728231, Serial #: 4021, 9535, 9544, 9587, 9627, 9701, 9707, 9713, 9759, 9875, 9887, 9917, 9925, 9931, 9980, 9996, 10009, 10011, 10012, 10015, 10028, 10036, 10042, 10045, 10050, 10052, 10062, 10063, 10064, 10077, 10079, 10081, 10096, 10099, 10102, 10111, 10114, 10120, 10122, 10135, 10136, 10137, 10139, 10145, 10148, 10149, 10151, 10152, 10153, 10154, 10162, 10165, 10166, 10170, 10171, 10172, 10173, 10188, 10189, 10191, 10196, 10198, 10203, 10214, 10222, 10227, 10228, 10229, 10230, 10235, 10238, 10242, 10243, 10247, 10259, 10260, 10261, 10263, 10268, 10273, 10274, 10278, 10288, 10291, 10293, 10294, 10297, 10298, 10301, 10302, 10307, 10312, 10313, 10316, 10317, 10318, 10319, 10320, 10327, 10336, 10337, 10341, 10347, 10349, 10350, 10351, 10352, 10353, 10362, 10365, 10376, 10380, 10384, 10387, 10393, 10400, 10411, 10412, 10414, 10431, 10438, 10439, 10445, 10446, 10452, 10453, 10459, 10461, 10468, 10470, 10471, 10476, 10482, 10486, 10490, 10491, 10503, 10511, 10513, 10519, 10535, 10536, 10540, 10544, 10546, 10551, 10554, 10561, 10563, 10568, 10569, 10574, 10582, 10600, 10617, 10628, 10631, 10635, 10646, 10647, 10651, 10655, 10659, 10673, 10684, 10686, 10698, 10714, 10733, 10734, 29002, 29014, 29016, 29027, 90054, 90099, 95022, 95046, 95073, 95103, 95107, 95109, 95114, 95132, 95133, 95181, 95209, 95268, 95295, 95305, 95371, 95453, 95473, 95563, 95660, 95704, 95706, 95707, 95712, 95715, 95721, 95727, 95729, 95769, 95778, 90199 & 95162. Model #, 728235, Serial #: 9034, 9190, 9233, 9234, 9261, 29049, 29057, 29064 & 29149. Model #, 728246, Serial #: 3150, 3163, 4051, 5547, 5585, 5623, 5655, 5666, 5670, 5715, 5724, 5747, 5773, 5776, 5791, 5803, 5813, 5836, 5855, 5862, 5868, 5876, 5877, 5897, 5911, 5916, 5935, 5969, 5971, 5974, 5997, 6001, 6006, 6008, 6028, 6087, 6102, 6117, 6120, 6121, 6126, 6170, 6195, 6200, 6202, 6203, 6238, 6243, 6281, 6287, 6306, 6318, 6324, 6346, 6352, 6387, 6402, 6405, 6444, 6484, 6491, 6494, 6495, 6496, 6503, 6517, 6519, 6523, 6556, 6559, 6609, 6610, 6611, 6612, 6623, 6624, 6640, 6642, 50115, 50147, 50166, 50180, 50189, 50193, 50195, 50197, 50198, 50204 & 50043. Model #, 728256, Serial #: 3490, 3500, 3679 & 3693.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2210-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2210-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-16

Product code JAK

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)