FDA Device recall Z-0546-2019
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the…
- FDA Device
- Class II
- terminated
- Published 2018-12-12
On 2018-12-12 the FDA classified a Class II recall of Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the… 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-0546-2019 |
| 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 16 Slice (Air), Model 728246 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: 646 1554 3007 3010 3011 3012 3013 3014 3015 3016 3017 3018 3020 3023 3027 3029 3…System Serial Number: 646 1554 3007 3010 3011 3012 3013 3014 3015 3016 3017 3018 3020 3023 3027 3029 3030 3031 3038 3040 3041 3043 3047 3050 3057 3059 3070 3072 3082 3085 3090 3095 3103 3110 3111 3117 3123 3127 3135 3141 3149 3150 3160 3161 3162 3163 3164 3170 3179 3185 3189 3191 3202 3205 3216 3217 3219 3224 3227 3244 3247 3279 3286 3290 3291 3293 3294 3295 3300 3302 3304 3306 3314 3324 3329 3331 3335 3356 3359 3373 3376 3382 3392 3393 3407 3421 3423 3435 3441 3442 3444 3458 3465 3466 3473 3478 3482 3490 3514 3521 3526 3535 3563 3565 3570 3588 3603 3616 3624 3647 3650 3665 3673 3720 3721 3769 3841 4004 4013 4015 4017 4018 4019 4024 4025 4036 4037 4038 4041 4042 4045 4046 4051 4055 5001 5002 5004 5005 5006 5007 5008 5010 5011 5012 5013 5014 5015 5016 5017 5018 5019 5020 5021 5022 5023 5024 5025 5026 5027 5028 5029 5030 5031 |
|---|
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-0546-2019%22
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