FDA Device recall Z-0694-2017
Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of…
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of… by Philips Medical Systems Cleveland, citing software error due to the filament on timer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0694-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-12 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Brilliance 64 728232 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Reason
Software error due to the filament on timer
Identifiers
| code_info | 122921, 123029, 123092, 123096, 123116, 123117, 123148, 123150, 123164, 123170, 123172, 123176, 123179, 123180, 123182, 123183, 123185 and 123191 |
|---|
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-0694-2017%22
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