FDA Device recall Z-0548-2019
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the b…
- FDA Device
- Class II
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class II recall of Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the b… 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-0548-2019 |
| 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 6 Slice (Air), Model 728256 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: 365 3001 3002 3003 3004 3005 3006 3009 3014 3019 3021 3022 3024 3025 3026 3028 3…System Serial Number: 365 3001 3002 3003 3004 3005 3006 3009 3014 3019 3021 3022 3024 3025 3026 3028 3029 3030 3032 3033 3034 3035 3036 3037 3039 3044 3045 3046 3048 3049 3051 3052 3053 3054 3055 3056 3058 3060 3061 3062 3063 3064 3065 3066 3067 3068 3069 3071 3073 3074 3075 3076 3077 3078 3079 3080 3081 3083 3084 3086 3088 3089 3091 3092 3093 3094 3096 3097 3099 3101 3102 3104 3105 3106 3107 3108 3109 3112 3113 3114 3115 3116 3118 3119 3120 3121 3122 3124 3125 3126 3128 3129 3130 3131 3132 3134 3135 3136 3137 3138 3139 3140 3142 3143 3144 3145 3146 3147 3148 3151 3152 3153 3154 3155 3156 3157 3158 3159 3162 3165 3166 3167 3168 3169 3171 3172 3173 3174 3175 3176 3177 3178 3180 3181 3182 3183 3184 3186 3187 3188 3190 3192 3193 3194 3195 3196 3198 3199 3200 3201 3203 3204 3206 3207 3208 3209 3210 3211 3212 3213 3214 3215 3218 |
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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-0548-2019%22
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