FDA Device recall Z-0543-2019
Brilliance 64, Model 728231 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 64, Model 728231 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-0543-2019 |
| 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 64, Model 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. 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: 335 1489 1897 3491 4001 4003 4016 4021 9009 9029 9030 9033 9035 9037 9038 9040 9…System Serial Number: 335 1489 1897 3491 4001 4003 4016 4021 9009 9029 9030 9033 9035 9037 9038 9040 9041 9043 9044 9045 9047 9048 9051 9052 9054 9056 9058 9059 9062 9064 9065 9066 9067 9068 9069 9070 9071 9072 9073 9074 9075 9077 9080 9081 9086 9087 9089 9092 9093 9096 9098 9099 9104 9105 9106 9107 9108 9112 9117 9118 9120 9121 9122 9134 9135 9137 9138 9139 9140 9142 9143 9148 9151 9152 9156 9159 9160 9162 9163 9166 9168 9171 9172 9173 9177 9187 9190 9194 9195 9196 9197 9201 9202 9205 9206 9208 9213 9214 9215 9216 9217 9218 9234 9235 9236 9243 9250 9251 9255 9259 9263 9268 9269 9272 9280 9286 9367 9501 9502 9503 9504 9505 9506 9507 9508 9509 9510 9511 9512 9513 9514 9515 9516 9517 9518 9519 9520 9521 9522 9523 9524 9525 9526 9527 9528 9529 9530 9531 9532 9533 9534 9535 9536 9537 9538 9539 9540 9541 9542 9543 9544 9545 9546 |
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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-0543-2019%22
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