CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report
Brilliance 64 CT Model number 728231 Product Usage: Computed recalled
Philips Medical Systems (Cleveland) is recalling Brilliance 64 CT Model number 728231 Product Usage: Computed, distributed nationwide in the US. The recall was initiated on 20 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2652-2016
- FDA event ID
- 74820
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2016
- FDA classified
- 25 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 20 Jul 2016 | Recall initiated by company | |
| 25 Aug 2016 | Classified by FDA | +36 days |
| 31 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brilliance 64 CT Model number 728231 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.
Where it was distributed
US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Brilliance 64 CT Model number 728231 Product Usage: Computed recalled?
Yes. Philips Medical Systems (Cleveland) recalled Brilliance 64 CT Model number 728231 Product Usage: Computed on 20 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2652-2016.
Why was it recalled?
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Which lots are affected?
9033 9037 9043 9045 9064 9065 9070 9075 9086 9089 9104 9108 9120 9151 9156 9172 9190 9243 9259 9507 9508 9511 9526 9530 9531 9534 9547 9564 9580 9584 9598 9603 9606 9608 9613 9614 9630 9642 9655 9672 9695 9697 9690 9706 9713 9732 9735 9736 9757 9759 9812 9830 9835 9866 9875 9881 9889 9918 9936 9937 9951 9965 9968 9969 9975 9978 9992 9999 10036 10041 10046 10054 10067 10070 10080 10095 10103 10125 10141 10256 10292 10359 10363 10372 10380 10381 10386 10426 10473 10486 10505 10513 10527 10535 10561 10570 10645 10651 10655 10673 10686 10733 10743 10773 10776 29007 29016 29018 29025 29027 29037 29053 29097 90031 90047 90063 90128 95003 95058 95068 95210 95357 95811 29054 9107 9666 9700 29038 9858 9009 9029 9038 9051 9058 9067 9068 9072 9073 9092 9105 9106 9502 9503 9512 9516 9522 9525 9533 9545 9550 9551 9556 9572 9577 9591 9594 9596 9612 9618 9620 9624 9625 9626 9628 9633 9634 9635 9639 9641 9648 9650 9663 9676 9678 9685 9691 9692 9694 9705 9716 9726 9729 9740 9750 9751 9752 9753 9754 9775 9777 9780 9788 9790 9793 9809 9811 9821 9823 9826 9843 9846 9855 9857 9861 9869 9873 9878 9879 9882 9885 9894 9895 9902 9906 9917 9924 9938 9942 9948 9954 9960 9961 9966 9974 9982 9985 9994 10001 10014 10035 10037 10045 10065 10079 10085 10086 10096 10098 10111 10112 10113 10120 10148 10190 10200 10202 10224 10263 10291 10310 10332 10353 10365 10370 10371 10388 10413 10417 10424 29005 29035 29068 64015 90062 95008 95057 95348 9851T 10122 10373 10211 9139 10005 10026 10030 10031 10194 95149 95377 95392 9980 9698 9787
Where was it sold?
US Nationwide Distribution in the states of: AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA, MD,ME,MI,MN,MO,MS,NC,ND,NE,NJ,NM, NV,NY,OH,OK,OR,PA,PR,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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