FDA Device recall Z-2368-2016
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstr…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstr… by Philips Medical Systems Cleveland, citing software defect causing intermittently slow response of Host.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2368-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-24 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV, WY |
Product
Brilliance BigBore Radiology 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.
Reason
Software defect causing intermittently slow response of Host.
Identifiers
| code_info | Model #: 728244; Serial #s: 7052, 7172, 7200, 7244, 7252, 7375, 7380, 7384, 7390, 7514, 7533, 7546, 7614, 7633, 7708, 7781, 7789. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2368-2016%22
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