{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Cleveland", "state": "OH", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "81569", "recalling_firm": "Philips Medical Systems (Cleveland) Inc", "address_1": "595 Miner Rd", "address_2": "N/A", "postal_code": "44143-2131", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-0548-2019", "product_description": "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", "product_quantity": "6,343 units in total", "reason_for_recall": "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", "recall_initiation_date": "20181018", "center_classification_date": "20181130", "termination_date": "20210803", "report_date": "20181212", "code_info": "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 3477 3479 3480 3481 3483 3484 3485 3486 3487 3488 3489 3491 3492 3493 3494 3495 3496 3497 3498 3499 3500 3501 3502 3503 3504 3505 3506 3507 3508 3509 3510 3511 3512 3513 3515 3516 3517 3518 3519 3520 3522 3523 3524 3525 3527 3528 3529 3530 3531 3532 3533 3534 3535 3536 3537 3538 3539 3540 3541 3542 3543 3544 3545 3546 3547 3548 3549 3550 3551 3552 3553 3554 3555 3556 3557 3558 3559 3560 3561 3562 3564 3566 3566 3567 3568 3569 3570 3571 3572 3573 3574 3575 3576 3577 3578 3579 3580 3581 3582 3583 3584 3585 3586 3587 3589 3590 3591 3592 3593 3594 3595 3596 3597 3598 3599 3600 3601 3602 3604 3605 3606 3607 3608 3609 3610 3611 3612 3613 3614 3615 3617 3618 3619 3620 3621 3622 3623 3625 3626 3627 3628 3629 3630 3631 3632 3633 3634 3635 3636 3637 3638 3639 3640 3641 3642 3643 3644 3645 3646 3648 3649 3651 3652 3653 3654 3655 3656 3657 3658 3659 3660 3661 3662 3663 3664 3666 3667 3668 3669 3670 3671 3672 3674 3675 3676 3677 3678 3679 3680 3681 3682 3683 3684 3685 3686 3687 3688 3689 3690 3691 3692 3693 3694 3695 3696 3697 3698 3699 3700 3701 3702 3703 3704 3705 3706 3707 3708 3709 3710 3711 3712 3713 3714 3715 3716 3717 3718 3719 3720 3722 6040 9773 9775 30001 30002 30003 30004 30005 30007 30008 30009 30010 30011 30012 30013 30014 30015 30016 30017 30018 30022 30024 30025 30026 30027 30028 30029 30030 30031 30034 30035 30036 30037 30038 30039 30040 30042 30043 30045 30046 30047 30048 30050 30052 30053 30054 30055 30056 30057 30058 30059 30060 30061 30062 30064 30065 30066 30069 30072 30073 30074 30075 30076 30077 30078 30079 30080 30082 30083 30084 30085 30086 30087 30088 30089 30092 30095 30096 30098 30100 30102 30103 30104 30105 30106 30107 30108 30110 30111 30112 30113 30114 30116 30117 30118 30120 30121 30122 30123 30124 30125 30126 30127 30128 30129 30130 30131 38974058 39252699 52245701 52245740 52245779 62985040 69541183 70521161 _3616 3132.F 3273/8898 334/30006 3432_ 3528_ 3561_ 365/30010 4173-01 4229-03 4256-03 4447-01 447*008-Brilliance 728256_603-1837 728256_803-1616 9799/9790 SN3432" } ] }