FDA Device recall Z-0544-2019
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comp…
- FDA Device
- Class II
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class II recall of Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comp… by Philips Medical Systems Cleveland, citing there is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0544-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-18 |
| Published | 2018-12-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance 40, Model 728235 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. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
Reason
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
Identifiers
| code_info | System Serial Number: 938 1513 1520 4012 4022 9031 9032 9034 9036 9039 9042 9046 9047 9050 9053 9055 9…System Serial Number: 938 1513 1520 4012 4022 9031 9032 9034 9036 9039 9042 9046 9047 9050 9053 9055 9057 9060 9061 9063 9076 9078 9079 9082 9083 9084 9085 9088 9090 9091 9094 9095 9097 9100 9101 9102 9103 9109 9110 9111 9112 9113 9114 9115 9116 9119 9122 9123 9124 9125 9126 9127 9128 9129 9130 9131 9132 9133 9136 9141 9144 9145 9146 9147 9149 9150 9153 9154 9155 9157 9158 9161 9164 9165 9167 9169 9170 9174 9175 9176 9178 9179 9180 9181 9182 9183 9184 9185 9186 9187 9188 9189 9191 9192 9193 9198 9199 9200 9203 9204 9207 9209 9210 9211 9212 9219 9220 9221 9222 9223 9224 9225 9226 9227 9228 9231 9232 9233 9237 9238 9239 9240 9241 9242 9244 9245 9246 9247 9248 9249 9252 9253 9254 9256 9257 9258 9260 9261 9262 9264 9265 9266 9267 9270 9271 9273 9274 9275 9276 9277 9278 9279 9281 9282 9283 9284 9285 22149 29004 29006 29008 29009 2 |
|---|
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-0544-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.