Brilliance 6 Slice (Air)
Medical device recall Z-0548-2019. Published in FDA’s Enforcement Report on Dec 12, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 12, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 6,343 units in total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
6,343 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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 3220 3221 3222 3223 3225 3226 3227 3228 3229 3230 3230 3231 3231 3232 3233 3233 3234 3235 3237 3238 3239 3239 3240 3241 3242 3243 3244 3245 3246 3248 3249 3250 3251 3252 3253 3254 3255 3256 3257 3258 3259 3260 3261 3262 3263 3264 3265 3266 3267 3268 3269 3270 3271 3272 3273 3274 3275 3276 3277 3278 3280 3281 3282 3283 3284 3285 3287 3288 3289 3290 3292 3296 3297 3298 3299 3301 3303 3305 3307 3308 3309 3310 3311 3312 3313 3315 3316 3317 3318 3319 3320 3321 3322 3323 3325 3326 3327 3328 3330 3331 3332 3333 3334 3336 3337 3338 3339 3340 3341 3342 3343 3344 3345 3346 3347 3348 3349 3350 3351 3352 3353 3354 3355 3356 3357 3358 3359 3360 3361 3362 3363 3364 3366 3367 3368 3369 3370 3371 3372 3373 3374 3375 3377 3378 3379 3380 3381 3382 3383 3384 3385 3386 3387 3388 3389 3390 3391 3394 3395 3396 3397 3398 3399 3400 3401 3402 3403 3404 3405 3406 3408 3409 3410 3411 3412 3413 3414 3415 3416 3417 3418 3419 3420 3421 3422 3424 3425 3426 3427 3428 3429 3430 3431 3432 3433 3434 3435 3436 3437 3438 3439 3440 3443 3445 3446 3447 3448 3449 3450 3451 3452 3453 3454 3455 3456 3457 3459 3460 3461 3462 3463 3464 3467 3468 3469 3470 3471 3472 3473 3474 3475 3476…
FDA’s list runs to 4,017 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 18, 2018.
- FDA classified it on Nov 30, 2018.
- FDA’s Enforcement Report published it on Dec 12, 2018.
- FDA terminated it on Aug 3, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Medical Systems (Cleveland) Inc, of Cleveland, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,017 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.