FDA Device recall Z-1493-2017
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comput…
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comput… by Philips Medical Systems Cleveland, citing philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1493-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-23 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX, WI |
Product
Brilliance BigBore Radiology CT - 728244 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. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Reason
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Identifiers
| code_info | System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique…System Serial Number - 76001, 76005, 76007, 76009, 76013, 76014, 76017, 76018, 76019, System Serial Number - Unique Device Identifier 76058 (01)00884838059450(21)76058 76033 (01)00884838059450(21)76033 76048 (01)00884838059450(21)76048 76059 (01)00884838059450(21)76059 76015 (01)00884838059450(21)76015 76063 (01)00884838059450(21)76063 76066 (01)00884838059450(21)76066 76049 (01)00884838059450(21)76049 76040 (01)00884838059450(21)76040 76032 (01)00884838059450(21)76032 76061 (01)00884838059450(21)76061 76031 (01)00884838059450(21)76031 76006 (01)00884838059450(21)76006 76041 (01)00884838059450(21)76041 76035 (01)00884838059450(21)76035 76038 (01)00884838059450(21)76038 76065 (01)00884838059450(21)76065 76064 (01)00884838059450(21)76064 76053 (01)00884838059450(21)76053 76050 (01)00884838059450(21)76050 76060 (01)00884838059450(21)76060 76036 (01)00884838059450(21)76036 76056 (01)00884838059450(21)76056 76055 (01)00884838059450(21)76055 76037 (01)00884838 |
|---|
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-1493-2017%22
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